Neoplasms

Digestive System Diseases

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Sarcopenia

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Amino Acids

All Drugs and Chemicals

Glutamine

15 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding

10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding

oral glutamine

Maltodextrin

Jin-Ming Wu, MD

Glutamine has the potentials of immunomodulation and adjustment of protein metabolism. The primary objective of this study is to evaluate the efficacy of glutamine on sarcopenia in gastric adenocarcinoma patients undergoing gastrectomy. The secondary endpoints, including the physical activity, weight loss, and nutritional profiles, will be evaluated among these patients.

This will be a double-blind, randomized, and placebo-controlled study. At least 80 evaluable patients who are scheduled for gastrectomy for gastric adenocarcinoma cancer will be randomly assigned to the control or treatment group. Each group will have at least 40 patients. The CT scan will be evaluated before surgery and on postoperative day (POD) 90. Moreover, the patient will wear the smart watch to record daily walking steps. Laboratory data will be check before gastrectomy and on POD 90.

Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy

the average daily walking steps recorded by the wearable devices

National Taiwan University Hospital

Jin-Ming Wu, Clinical Associate Professor & PhD

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphosarcoma

A prebiotic nutritional supplement available at commercial grocery and health food stores. Specifically, we will be using Bob's Red Mill® potato starch.

Resistant Starch

A starch commonly used as a placebo in prebiotic trials that is digested in the stomach and rapidly absorbed

Jayson Henrickson, MS

Taylor A Johnson, BS, MA

Christopher R D'Angelo, MD

Higher gut microbiome diversity has been associated with improved survival following autologous stem cell transplantation in multiple myeloma and lymphoma. This study hypothesises that prebiotic supplementation with resistant starch (RS) will improve gut microbiome diversity at time of stem cell engraftment. To test this, participants will either have RS or a placebo (maltodextrin) mixed into a food item of their choice for approximately 10 days prior to stem cell infusion and continue to the first day of neutrophil engraftment. The study will look at the difference in gut microbiome diversity between the RS and placebo arm collected at the engraftment timepoint, dietary evaluation to assess the impact of subject diet on microbiome response to intervention and serum sample collection to assess differences to gut permeability during transplant.

Higher gut microbiome diversity has been associated with improved survival following autologous stem cell transplantation in multiple myeloma and lymphoma, but no strategies have been identified to date that specifically target the gut microbiome. The investigators hypothesize that prebiotic supplementation with resistant starch (RS) will improve gut microbiome diversity at time of stem cell engraftment.

To test this hypothesis, the study will be a randomized, double-blind, placebo-controlled trial of resistant starch versus placebo (maltodextrin) in participants with myeloma or lymphoma undergoing autologous stem cell transplantation. Thirty subjects will be randomized 1:1 to the RS or placebo arm, dosed at 20g daily for 3 days followed by an increased to 20g twice a day mixed into a food item of the participant's choice. The intervention will begin approximately 10 days prior to stem cell infusion and will continue until the first day of neutrophil engraftment (first day absolute neutrophil count \>500) or approximately 30 days in total. Fecal samples will be collected at 4 timepoints for microbiome analysis: 1) at study enrollment 2) day of stem cell infusion 3) day +7 post auto transplant and 4) first day of engraftment defined as absolute neutrophil count \>500 (approximately 10-14 days post-transplant).

The primary endpoint will be the difference in gut microbiome diversity between the RS and placebo arm collected at the engraftment timepoint. Secondary endpoints will include dietary evaluation to assess the impact of subject diet on microbiome response to intervention and serum sample collection to assess differences to gut permeability during transplant.

Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Stem Cell Transplantation

A Pilot, Randomized, Double-blind, Placebo-controlled Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Stem Cell Transplantation in Multiple Myeloma and Lymphoma: The PRIMAL Trial

To understand the feasibility of the intervention in the proposed study population, the percentage of subjects who adhere to \>70% of scheduled doses will be calculated

To evaluate the duration of hospitalization according to intervention assignment by measuring time from stem cell transplant to day of discharge.

To estimate the rate of neutropenic fever in the post-transplant setting according to intervention assignment. This is captured by cumulative incidence of neutropenic fever (ANC \<1000, temperature \>38.0⁰C) by day 30 according to intervention assignment

To determine the rate of broad-spectrum antibiotic exposure during transplant according to intervention assignment by measuring the proportion of subjects receiving systemic antibiotic exposure.

To determine the rate of gastrointestinal symptoms according to intervention assignment by using the patient-reported gastrointestinal symptom rating scale (GSRS.)

University of Nebraska

Head and Neck Neoplasms

Patients will receive the symbiotic product LactoFos twice a day during seven days after surgical treatment. The intervention consists of giving twice a day a sachet of 6g of symbiotic diluted in 20mL of water via nasoenteric tube for seven days, totaling the administration of 14 sachets per intervention.

Patients will receive 6g of maltodextrin twice a day during seven days after surgical treatment.

Intervention will consist of the adminitration of symbiotic product twice a day during seven days after surgical treatment

Symbiotic

Intervention will consist of the adminitration of placebo product twice a day during seven days after surgical treatment

Priscilla C Lages, bachelor

The purpose of this study is to determine whether the symbiotic use in patients with head and neck cancer impact on intestinal function after surgical treatment.

The study will be conducted offering the patients symbiotic product twice a day for seven days after the surgical treatment. Patients will be monitored for the number of stools, stools consistency, abdominal pain and gas overproduction.

Impact of Symbiotic Administration on Intestinal Function of Head and Neck Patients Surgically Treated

Intestinal Function of Patients With Uper Air and Digestive Neoplasia Submitted to Surgical Treatment: Symbiotic Use Impact

The intestinal permeability using serum DAO enzyme concentration (ng/mL) was determined by sandwich enzyme-linked immunosorbent assay (ELISA) kit (SEA656Hu), according to Cloud-Clone Corporation® (Huston, TX) specifications.

Federal University of Minas Gerais

Patients received, twice a day, the symbiotic product (LactoFos) for at least 5 days and the maximum of 7 days.

Patients will receive twice a day the placebo product (Maltodextrin) or at least 5 days and the maximum of 7 days.

Total

Age, Categorical

Sex: Female, Male

Nourished

Malnourished

Nutritional status

Dr. Maria Isabel Correia

Serum DAO Enzyme Concentration

Infection Rate

Patients will receive twice a day the symbiotic product during seven days after surgical treatment

LactoFos: Patients will receive the product twice a day during seven days after surgical treatment

Patients will receive twice a day the placebo product during seven days after surgical treatment

Maltodextrin: Patients will receive maltodextrin twice a day during seven days after surgical treatment

Overall Study

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Soluble Corn Fiber

Heather Green, MS

Chase Zibilich

Li Li, MD, PhD

Brian Kann, MD

H. David Vargas, MD

William Johnston, MD

Jennifer Paruch, MD

Charles Whitlow, MD

William Kethman, MD

Marc Matrana, MD

Jonathan Mizrahi, MD

Daniel Johnson, MD

A significant racial disparity in the incidence and mortality of CRC exists in the U.S. with African Americans having CRC incidence and mortality rates that are 20% and 40% higher than the general U.S. population. It has been demonstrated that the gut microbiome impacts tumor development and progression through multiple mechanisms, including impacting the tumoral immune response. However, it is unknown if microbiome modulating treatment can have an impact on CRC outcomes.

A significant racial disparity in the incidence and mortality of CRC exists in the U.S. with African Americans having CRC incidence and mortality rates that are 20% and 40% higher than the general U.S. population. It has been demonstrated that the gut microbiome impacts tumor development and progression through multiple mechanisms, including impacting the tumoral immune response. However, it is unknown if microbiome modulating treatment can have an impact on CRC outcomes.

This is a pilot project to see if any changes are detected in stool and/or tissue samples in rectal cancer patients who receive a soluble corn fiber supplement during their neoadjuvant treatment.

Prebiotics in Rectal Cancer

Do Prebiotics Change Intestinal Biome in Rectal Cancer Patients Undergoing Neoadjuvant Therapy

fiber supplements with prebiotic effects modulate the gut and tumor associated microbiome leading to improved outcomes in stage II and III rectal cancer patients

To characterize the changes in the gut and tumor associated microbiome

To evaluate the impact of prebiotic fiber treatment and microbiome changes on the tumor immune profile known to be associated with favorable outcomes

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy	NCT06027242	Gastric Cancer Immunonutrition Gastrostomy	oral glutamine Maltodextrin	20 Years -	National Taiwan University Hospital
Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Stem Cell Transplantation	NCT05135351	Multiple Myelom... Lymphoma	Resistant Starc... Maltodextrin	19 Years -	University of Nebraska
Impact of Symbiotic Administration on Intestinal Function of Head and Neck Patients Surgically Treated	NCT02654652	Head and Neck C... Synbiotics Nutrition Thera...	Symbiotic Maltodextrin	18 Years -	Federal University of Minas Gerais
Prebiotics in Rectal Cancer	NCT05516641	Rectal Cancer	Soluble Corn Fi... Maltodextrin	18 Years -	Ochsner Health System
Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy	NCT06027242	Gastric Cancer Immunonutrition Gastrostomy	oral glutamine Maltodextrin	20 Years -	National Taiwan University Hospital

Spots Global Cancer Trial Database for maltodextrin

Every month we try and update this database with for maltodextrin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.