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Herbal and Botanical

Psyllium

Calcium polycarbophil

The participants are allocated to intake the fifteen capsules per day, for example, five capsules three times per day. Altogether the fifteen capsules contains 5.5 g dietary fiber in psyllium husk.

The participants are allocated to intake the fifteen capsules per day, for example, five capsules three times per day. The capsules contain placebo (maltodextrin) and have a similar look as in the experimental arm.

The participants are invited to eat 15 capsules per day. The capsules either contain dietary fiber from psyllium husk or placebo.

Capsules containing either dietary fiber or placebo

Rebecca Ahlin, M.Sc.

Daniel Munkberg, Dietician

Johanna Svensson, MD

Gunnar N Steineck, MD, PhD

Maria Hedelin, PhD

Cecilia Bull, PhD

The investigators hypothesize that an increase in dietary fiber intake during radiation therapy may provide better long-term intestinal health for the cancer survivor. If the hypothesis is not correct, the increased intake may only mean an increase in acute side effects. All participants are advised to consume at least 16 g of dietary fiber/day via food. In addition, participants are invited to take capsules that together contain either 5.5 g of dietary fiber from psyllium husk or placebo.

The overall working hypothesis is that intake of dietary fiber during radiotherapy can mitigate or hinder end states or the triggering of long-lasting pathophysiological processes that decreases intestinal health in the cancer survivor. If correct, there is a dose-effect relationship to be documented. Moreover, if correct, different kinds of dietary fibers may have different effects. Mechanisms for the mitigatory effects may be that dietary fiber helps to preserve the two protective mucus layers and hinder gut-wall starvation. Lack of protection, as well as gut-wall starvation, may decrease the gut walls' integrity. That, in turn, may enhance bacterial migration from the lumen into the gut wall, causing unnecessary inflammation. This inflammation may, in turn, lead to a number of different pathophysiological processes, including a chronic self-propagating low-grade inflammation. Clinical experience suggests the intake of dietary fiber during radiotherapy may increase acute intestinal side effects. Our own data suggest a modest, if any, increase by dietary fiber.

Through recipes of tasty meals by price-winning chefs and general advice, the investigators guide the participant to try to consume at least 16 g of dietary fiber per day via food. The guidance takes place through telephone calls, calls via video link, and text on a website or paper material. The participant gets access to a mobile application that measures the daily intake of dietary fiber. Dietary fiber is ingested in 15 capsules with psyllium husk which contains a total of 5.5 g of dietary fiber. The investigators ask the participant to take the capsules two weeks before radiotherapy, during radiotherapy, and to stop four weeks after the end of radiotherapy. Placebo capsules (maltodextrin) are taken in the same way. To document the frequency of acute side effects, and what symptoms they cause, the participant is asked to report patient-reported outcomes once a week via a mobile application. They are also welcome to report side effects to the study office.

One month after the end of radiotherapy, the degree of inflammation is measured via markers in the blood and feces. One year after the end of radiotherapy, intestinal health is measured via patient-reported outcomes. Blood and feces are collected and patient-reported outcomes are reported in questionnaires and a mobile application before, during, and at least one year after the end of radiotherapy. This data will be a source of in-depth analysis. Radiotherapy gives rise to increased intensity of five different syndromes, fecal-leakage syndrome, urgency syndrome, uncontrolled flatulence, excess mucus discharge, and anal blood discharge. Damage of nerves and small vessels, weakening the anal-sphincter function by muscle fibers turning into the connective tissue (fibrosis), may explain some of the intensity of the fecal-leakage syndrome. An ongoing self-propagating low-grade inflammation, small-vessel and nerve damage in the gut wall may be related to urgency. Reasonably the microbiome, and the communication between the microbiome and the gut wall, is related to uncontrolled flatulence and excess mucus discharge. It is not known to what extent telangiectasias on a fibrotic inner gut wall explains anal blood discharge. Ad hoc studies in FIDURA will explore suggested mechanisms.

An interim analysis will be performed for the primary outcome to identify if there is any effect of the intervention, to decide whether to continue or terminate the inclusion of patients in the study. The concentration of c-reactive protein will be analyzed for all included patients who have donated blood to date (May 2023). To ensure that the blinding is not revealed, all analyses (biochemical and statistical) will be made by external personnel not included in the research group. The capsules are marked with X and Y, and the code for which is intervention or placebo will not be revealed even for the external personnel performing the interim analysis.

Random allocation of patients and blinding of researchers, patients, healthcare professionals and outcome assessors.

Capsules that look alike, with dietary fiber or placebo.

Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial

Dietary Fiber During Radiotherapy and Intestinal Inflammation - a Placebo-controlled Randomized Trial (FIDURA)

As soon as we we have started publishing data we will successively make our data available to other researchers.

Metrics obtained from freshly frozen defecated feces. The investigators plan to use next-generation sequencing.

Concentration of c-reactive protein in plasma or serum

Patient-reported outcomes through a validated questionnaire. The metric for the intensity of the urgency syndrome weighs the frequency of several symptoms by factor loadings, as described in PubMed ID 28158314. Examples of the previous usage can be seen in PubMed ID 28366105 and PubMed ID 30601820.

Deviation from the recommended intake of 15 capsules per day

Concentration of selected markers in blood and feces. The selection of cytokines and chemokines for this outcome is work in progress 26 august 2020 and will be be given as updated information later on. In feces we will primarily use elastase and calprotectin.

Patient-reported outcomes through a validated questionnaire. The metric for the intensity of the syndromes weighs the frequency of several symptoms by factor loadings, as described in PubMed ID 28158314. Examples of the previous usage can be seen in PubMed ID 28366105 and PubMed ID 30601820.

Distress from gastrointestinal symptoms as reported through a mobile phone application (ePROMS). Primarily we ask for defecation frequency, stool consistency (Bristol Scale), and frequency of abdominal pain. The participants may also report other side-effects, either by the mobile phone application, video link, or telephone with the study secretariat.

The Swedish Research Council

VGregion

Sjöbergstiftelsen

Sahlgrenska University Hospital, Sweden

Senior Professor

Carcinoma

Low Anterior Resection Syndrome

Postoperative Complications

Dermatologic Agents

Loperamide

Antidiarrheals

Coal Tar

Patients undergo a bowel management program comprising a medical management pathway (fiber, loperamide hydrochloride, pelvic floor physical therapy) in combination with RRE treatment for 1 year. Patients use the RRE system to self administer an individualized enema regimen via the rectum. Patients may undergo abdominal film x-rays throughout the trial.

Patients receive medical management comprising fiber, loperamide hydrochloride, and pelvic floor therapy for 1 year. If medical management fails, patients may then be referred for surgery with sacral nerve stimulator placement.

Dietary Fiber

Enema Administration

Loperamide Hydrochloride

Physical Therapy

Questionnaire Administration

X-Ray Imaging

The Ohio State Comprehensive Cancer Center

Alessandra C. Gasior, DO

Alessandra C Gasior, DO

This clinical trial studies if a bowel management program with a retrograde rectal enema (RRE) for the treatment of low anterior resection syndrome (LARS) in rectal cancer patients is better than medical management alone. Rectal cancer treatment can include a procedure where part of the rectum with cancer is removed and the remaining part of the rectum is reconnected to the colon, this is called a low anterior resection of the rectum. LARS is a common condition that can develop after undergoing a low anterior resection of the rectum. LARS consists of any change in how the body performs defecation, the discharge of feces from the body, after undergoing a resection procedure. Patients with LARS may experience fecal urgency, incontinence, increased frequency, constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Patients may experience individual symptoms of LARS or a combination of them. A bowel management program assists patient's with identifying a specific bowel management regimen that works best for managing symptoms of LARS. A RRE consists of inserting a catheter through the anus into the rectum. The RRE is designed to assist fecal emptying. Medical management of LARS can include the use of fiber, loperamide hydrochloride, or pelvic floor physical therapy. Fiber may help relieve constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Loperamide hydrocholoride may help lessen fecal urgency, incontinence, or increased frequency. Pelvic floor physical therapy may help restore strength in the rectum possibly helping to improve symptoms of LARS. Participating in a bowel management program with a RRE may be more effective in treating LARS than medical management alone.

PRIMARY OBJECTIVE:

I. To compare two approved pathways for treatment of low anterior resection syndrome (LARS) - a retrograde enema program versus a medical management pathway.

SECONDARY OBJECTIVE:

I. The determination of feasibility to complete this treatment pathway.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo a bowel management program comprising a medical management pathway (fiber, loperamide hydrochloride, pelvic floor physical therapy) in combination with RRE treatment for 1 year. Patients use the RRE system to self administer an individualized enema regimen via the rectum. Patients may undergo abdominal film x-rays throughout the trial.

GROUP II: Patients receive medical management comprising fiber, loperamide hydrochloride, and pelvic floor therapy for 1 year. If medical management fails, patients may then be referred for surgery with sacral nerve stimulator placement.

Upon completion of study intervention all patients are followed up at 1 month, 3 months, and 1 year.

A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients

Low Anterior Resection Syndrome: Retrograde Enema Program vs Medical Management

Will be measured using a validated scoring tool for LARS (Memorial Sloan Kettering Cancer Center Bowel Function Instrument Questionnaire \[MSKCC BFI\]). Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician.

Will be assessed using LARS validated scoring tool. Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician.

Will be assessed by administering a patient satisfaction survey post treatment. Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician.

Ohio State University Comprehensive Cancer Center

Principal Investigator

Anus Diseases

Cola

Patients receive dietary fiber PO QD for 28 days. Patients may undergo standard of care proctoscopy or anoscopy with biopsy on study and at follow up or may undergo standard of care colonoscopy on study. All patients also undergo collection of blood samples on study and at follow up.

Proctoscopy or anoscopy with Biopsy

Colonoscopy

Shahrose Rahman, M.D.

Amber O'Connor

Vassiliki L. Tsikitis, M.D.

Vassiliki L Tsikitis, M.D.

This clinical trial tests whether daily fiber supplementation will change the mucosal microbiome of the colon. The microbiome are microorganisms that live in the human gut. They serve a vital role in maintaining health. Certain microbial strains are associated with the growth of colon polyps, which eventually could go on to form colon cancer. Giving dietary fiber supplements may help prevent precancerous polyps from ever developing.

PRIMARY OBJECTIVE:

I. To identify how diet, specifically fiber supplementation, alters the microbiome of the colonic mucosa.

OUTLINE:

Patients receive dietary fiber orally (PO) once daily (QD) for 28 days. Patients may undergo standard of care proctoscopy or anoscopy with biopsy on study and at follow-up or may undergo standard of care colonoscopy on study. All patients also undergo collection of blood samples on study and at follow up.

Impact of Dietary Fiber Supplementation on Colonic Mucosal Microbiome

Changes in Colonic Microbiome With Fiber Supplementation

Will use data visualization techniques to understand the data and determine if microbiome count overall (richness) changes occur in patients who are started on fiber supplementation. In order to visualize overall changes after fiber supplementation, will generate plots showing relative abundance of the detected taxa for each subject at baseline and post-supplementation. For each taxa, will generate box plots to visually compare the median and interquartile range (IQR) of abundance between the two time points. Wilcoxon signed rank tests with an alpha level of 0.05 will determine if there is a difference in microbial derived short chain fatty acids after fiber supplementation in the blood and mucosa.

Will use data visualization techniques to understand the data and determine if the types of metabolites (microbiome diversity) cases occur in patients who are started on fiber supplementation. In order to visualize overall changes after fiber supplementation. To assess for changes in microbiome diversity, our primary analysis will compare median Shannon diversity index values at baseline and post-supplementation. The Shannon index estimates diversity using richness and abundance. Will calculate Shannon index values for each participant at each time point and use a Wilcoxon signed rank test with an alpha level of 0.05 to determine if there is a difference in microbiome diversity after fiber supplementation.

OHSU Knight Cancer Institute

Chicory

Subjects will receive personalized dietary advice (PDA) based on their habitual food pattern (as assessed using a food frequency questionnaire) and preferences. Based on a previously developed algorithm, the PDA provides fiber-rich alternatives for currently used low-fiber products, close to subjects' current eating behavior, to help increase dietary fiber intake. This PDA will be provided using an online web-portal.

Subjects will consume 2 sachets with each 7.5 g of dried cubes of chicory root, which equals a total of 12.3 g of dietary fiber per day. Subjects can choose when and how they consume the vegetable product, for example sprinkle it over their meal, or include in existing recipes.

Subjects will follow their habitual diet during the preoperative period.

Dietary intervention

Niels Klaassen, MSc

Dieuwertje EG Kok, PhD

Tjarda Heek, MD, PhD

The aim of this randomized controlled trial is to investigate the feasibility of increasing preoperative dietary fiber intake in individuals with colorectal cancer who will undergo surgery. This will be done using 1) digital personalized dietary advice or 2) a dried vegetable product compared to 3) habitual diet (control).

Rationale: Postoperative complications, affecting up to 50% of the patients with colorectal cancer (CRC) undergoing surgery, are associated with impaired quality of life and higher mortality rates. The investigators have previously shown an association between a higher preoperative dietary fiber intake and a lower risk of postoperative complications. Before large interventions aiming to evaluate potential causal relationships between dietary fiber and postoperative complications can be implemented, feasibility of increasing dietary fiber intake before CRC surgery needs to be explored.

Objective: To investigate the feasibility of increasing preoperative dietary fiber intake in CRC patients undergoing surgery via 1) personalized dietary advice (Vezel-UP tool), or 2) vegetable product containing natural fibers compared to 3) habitual diet (control group). Secondary objectives will be considered to generate preliminary (biological) data to support the design of a future large-scale intervention studies.

Study design: A randomized controlled trial with three groups: 1) Vezel-UP group, 2) vegetable product group, and 3) control group. The intervention period equals the time between diagnosis and surgery, which is on average \~4 weeks but will vary between individual patients depending on their characteristics (e.g., physical condition and tumor location) and waiting list.

Study population: 54 CRC patients who will undergo elective tumor resection.

Main study parameters/endpoints: The primary outcome is the change in dietary fiber intake, which is assessed via two 24hr dietary recalls at baseline and during and after the intervention. Secondary parameters are stool pattern, gastrointestinal symptoms, quality of life, fecal microbiota composition, fecal and plasma microbial metabolites levels (i.e., SCFA and indoles), and length of hospital stay.

A randomized controlled trial with three parallel arms consisting of two intervention arms and one control arm.

Dietary Fiber Before Colorectal Cancer Surgery

FiberUP in Clinical Practice: Increasing Preoperative Dietary Fiber Intake in Colorectal Cancer Patients.

Change in dietary fiber intake is assessed via two 24hr dietary recalls.

Change in stool frequency per week and average stool consistency per week assessed using the Bristol Stool Chart.

Change in gastrointestinal symptoms measured with the Gastrointestinal Symptom Rating Scale (GSRS). Higher scores mean a worse outcome.

Change in quality of life measured with the European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ-C30 \& CR29). Global and functional health-related quality of life will be calculated, for which higher scores indicate better quality of life. Also symptom scales will be calculated, for which higher scores indicate higher presence or severity of a symptom.

Measured using 16S rRNA amplicon sequencing in fecal samples.

Change in SCFA and indole concentrations determined by GC-MS/MS and LC-MS/MS in fecal samples.

Change in SCFA and indole concentrations will be determined by GC-MS/MS and LC-MS/MS in blood samples.

Time between surgery and hospital discharge in number of days based on data from medical records.

Gelderse Vallei Hospital

VLAG Graduate School

Alliance TU/e, WUR, UU, UMC Utrecht (EWUU)

Nutrition & Healthcare Alliance

WholeFiber BV

Wageningen Food and Biobased Research (WFBR)

Wageningen University

Assistant Professor, PhD

Participants first received a fiber supplement and a fish oil supplement PO daily for 30 days (Period 1). Participants entered a washout period for at least 60 days. For period 2 they received similarly packaged comparator (maltodextrin and corn oil)

Participants first received the comparator (maltodextrin and corn oil) supplement PO daily for 30 days (Period 1). Participants enter a washout period for at least 60 days. For period 2 they received the fiber supplement and a fish oil supplement

Fish Oil

Comparator

Given fish oil supplement placebo (corn oil)

Johanna Lampe

This trial studies how fiber and fish oil supplements affect the metabolism and activities of colon cells in healthy individuals. Diet is an important risk factor for colorectal cancer, and several dietary components important in colorectal cancer prevention are modified by gut microbial metabolism. Giving fiber and fish oil supplements may inhibit the growth of gut cells and ultimately reduce risk of colorectal cancer.

Participants are randomized to receive two dietary interventions in assigned random order. They either receive the dietary fiber supplement and fish oil supplement orally (PO) daily or they receive a fiber control and corn oil supplement daily for 30 days during the first intervention period. Then they enter a washout period for 60 days when they do not receive any treatment. After that they complete the second intervention period during which they receive the other intervention.

Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer

Diet and the Colonic Exfoliome: A Novel, Non-Invasive Approach to Testing Interventions in Humans

This grant is an R21 with the intent to provide preliminary data to propose a trial with a larger sample size and adequate statistical power.

Poly A+ RNA will be isolated from exfoliated cells in stool, and libraries generated from stool RNA will be sequenced on an Illumina HiSeq 2500 platform.

Serum Phospholipids - Eicosapentaenoic acid (EPA), concentration

National Cancer Institute (NCI)

Texas A&M University

Fred Hutchinson Cancer Center

Professor

Period 1: participants receive fiber supplement and fish oil supplements PO daily on days 1-30.

Washout: at least 60 days. Period 2: participants receive the comparators supplements also PO daily on days 90-120.

Cross-over Randomization 1: Fiber Plus Fish Oil Followed by Comparator

Period 1: participants receive the comparators supplements PO daily on days 1-30.

Washout: at least 60 days. Period 2: participants receive fiber supplement and fish oil supplements also PO daily on days 90-120.

Cross-over Randomization 2: Comparator Followed by Fiber Plus Fish Oil

Participants received a fiber supplement and fish oil supplement PO daily for 30 days. After a washout period, of at least 60 days, they received the comparator supplements (also for 30 days)

Participants received the comparator supplements PO daily for 30 days. After a washout period, of at least 60 days, they received the fiber supplement and fish oil supplement (also for 30 days)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

This is a pilot study with limited funding (R21 mechanism) thus sample size is small.

Dr. Johanna Lampe

Period 1: participants receive fiber supplement and fish oil supplement PO daily on days 1-30.

Washout: at least 60 days. Period 2: participants receive the comparators supplements also PO daily on days 90-120.

For Period 1: participants receive comparator supplements PO daily on days 1-30.

Participants enter a washout period for at least 60 days. For Period 2: participants receive fiber supplement and fish oil supplement also PO daily on days 90-120.

All participants who consented and started the intervention.

Feasibility and Retention for a Trial With Daily Doses of 35 g of Fiber and 6.2 g of EPA +DHA (and Corresponding Comparators)

Change in mRNA Expression Profiles in the Exfoliome

Daily Fiber plus Fish oil supplements (regardless of cross-over randomization order)

Fiber Plus Fish Oil Supplements

Compliance

Period 1: Fiber and Fish oil supplements (30 days) Washout: at least 60 days Period 2: Comparator supplements (30 days)

Period 1: Comparator supplements (30 days) Washout: at least 60 days Period 2: Fiber and Fish oil supplements (30 days)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial	NCT04534075	Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Gynecologic Can...	Capsules contai...	18 Years - 80 Years	Sahlgrenska University Hospital, Sweden
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients	NCT06424522	Low Anterior Re... Rectal Carcinom...	Dietary Fiber Enema Administr... Loperamide Hydr... Physical Therap... Questionnaire A... X-Ray Imaging	18 Years -	Ohio State University Comprehensive Cancer Center
Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial	NCT04534075	Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Gynecologic Can...	Capsules contai...	18 Years - 80 Years	Sahlgrenska University Hospital, Sweden
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients	NCT06424522	Low Anterior Re... Rectal Carcinom...	Dietary Fiber Enema Administr... Loperamide Hydr... Physical Therap... Questionnaire A... X-Ray Imaging	18 Years -	Ohio State University Comprehensive Cancer Center
Impact of Dietary Fiber Supplementation on Colonic Mucosal Microbiome	NCT05643859	Benign Colorect... Non-Neoplastic ...	Dietary Fiber Proctoscopy or ... Colonoscopy Questionnaire A...	18 Years -	OHSU Knight Cancer Institute
Dietary Fiber Before Colorectal Cancer Surgery	NCT06212817	Colorectal Canc...	Dietary interve...	18 Years -	Wageningen University
Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer	NCT04211766	Healthy Subject	Dietary Fiber Fish Oil Comparator Comparator	50 Years - 75 Years	Fred Hutchinson Cancer Center
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients	NCT06424522	Low Anterior Re... Rectal Carcinom...	Dietary Fiber Enema Administr... Loperamide Hydr... Physical Therap... Questionnaire A... X-Ray Imaging	18 Years -	Ohio State University Comprehensive Cancer Center

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