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Intestinal Neoplasms

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Colonic Diseases

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Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Amino Acids

Cola

Taurine

Participants on this arm will only consume their normal diet for 4 weeks.

Participants on this arm will consume an energy drink once daily in addition to their normal diet for 4 weeks.

Energy drink

Judy Walsh

Benjamin Burgess

Thomas George, MD

This study will investigate whether short-term daily energy drink consumption results in an increase in hydrogen sulfide-producing bacteria in adults 18-40 years old.

Colorectal cancer (CRC) is the 2nd leading cause of cancer deaths in the US. The bulk of new diagnoses typically occurs after the age of 50 for those without personal or family histories of this disease. However, rates of colorectal cancer have been slowly increasing in incidence in those younger than 50, recently prompting the U.S. Preventative Services Task Force to recommend reducing the age of routine screening to 45. The reason for the rising incidence of CRC in younger individuals (eoCRC) is unclear but with many speculative causes postulated. One of the most frequently cited possible causes relates to changes in the young adult colonic microbiome which either removes a protective mechanism or promotes a carcinogenic process. The latter is the hypothesis being persued.

Certain commensal bacteria produce hydrogen sulfide (H2S) during fermentation of sulfate containing compounds such as sulfur amino acids. For example, Fusobacterium nucleatum produces H2S from metabolizing methionine and cysteine. Atopobium parvulum is another potent H2S producer and is implicated in halitosis. Importantly, H2S has the capacity to induce inflammation and possesses genotoxic and potentially pro-tumorigenic properties, particularly when consistently present over a prolonged period of time. While Fusobacterium and Atopobium are minor members of the normal gut microbiota, recent studies showed that they are overrepresented in CRC patients. The invvestigators published that the relative abundance of A. parvulum was positively correlated with the severity of pediatric inflammatory bowel disease (IBD). Moreover, the investigators observed that Il10-/- mice colonized by A. parvulum developed severe colitis, which was attenuated by a chow diet containing the H2S scavenger bismuth. Together, this data suggests that bacteria-derived H2S may contribute to intestinal pathologies including the creation of a pro-inflammatory and pro-carcinogenic environment, which could be modulated by availability of dietary sulfur contents.

One major energy source for H2S producing gut microbiota is taurine, an essential amino acid found in very high levels/concentrations in energy drinks. The typical American diet provides between 123 and 178 mg of taurine daily. However, consumption of one 8-oz energy drink can increase the average taurine intake 6 to 16 times that our regular diet. The hypothesis being persued is that energy-drinks, through their high taurine content, favors expansion of already present bacteria producing H2S, thereby representing an association with a carcinogenic risk-factor that might help explain the rise in eoCRC cases and developing future interventions to mitigate this risk.

Study to Assess Colonic Microbiota Changes in Response to Energy Drink Consumption

Randomized Study to Assess Colonic Microbiota Changes in Response to Energy Drink Consumption

Determine the change in the hydrogen sulfide-metabolizing species of bacteria between baseline and study completion in those receiving the energy drink intervention compared to the control group, as measured by the change in the sulfur-metabolizing bacterial communities value in the stool

Determine changes to the colonic microbiota in participant stool samples between baseline and study completion and associated subject demographic differences and dietary intake

Determine the concordance of microbiome changes in participant stool samples with dietary logs

Determine overall change in microbial diversity in participant stool between baseline and study completion as measured by change in alpha diversity

Determine overall change in microbial diversity in participant stool between baseline and study completion as measured by change in Shannon diversity index

Determine subgroup analyses between the two arms regarding microbiome changes and tolerance with regards to gender, race, ethnicity, and baseline dietary meat/seafood/energy drink consumption

McJunkin Family Charitable Foundation

University of Florida

Carcinoma

Serum taurine was determined by High Performance Liquid Chromatography (HPLC) according to the pre-column extraction and derivatization methodology of McMahon et al. In the present work, we use Shimadzu HPLC model LC-10AT

Serum taurine results in this study showed that, besides CRC biomarkers; it is most attractive, more precious and more accurate early biomarker for early detecting of any malignant change which may led to CRC by other mean it is the most sensitive and more specific tumor marker for CRC. As a result, we can recommend measuring its level regularly with other prognostic tumor biomarkers and screening examination for all people with abdominal and gastrointestinal problems and for precancerous patients as a pre-early biomarker for colorectal carcinoma. So, it needs further studies to confirm that observations on large scale of population as it obvious the small sample size in early stage and lack data due to limited financial resources and it needs more efforts to collect first and precancerous stages patients.

Two-hundred and fifty Egyptian patients (males and females) who attended National Cancer Institute, Cairo university; most of them were referred from private clinics and non-specialized hospitals, complain with abdominal troubles and gastrointestinal problems and bleeding per rectum, after full investigation, clinical examination, biochemical analysis, screening examination according to their cases (Ultra sound, CT or endoscopy either rectal or colonoscopy) and histopathological examination, we choose 'after their approval' one-hundred patients and six which diagnosed as CRC patients aged (19-69 years old) and excluded the others from participated in these studies because they diagnosed as non-colonic diseases like; Irritable colon, Gastroenteritis, Pancreatitis, Liver flexure or Chronic cholecystitis. According to Histopathological architecture, we divided patients to:

1. Inflammatory group number=7.
2. Benign tumor group number=8 which was assessed preoperatively and postoperatively.
3. Malignant tumor group number=91 Lastly, ten health volunteers were enrolled as a frank control. For all included subjects, the measured biochemical analysis were CBC, ALT, AST, Albumin, Total Bilirubin, Creatinine, Blood urea, Sodium, Potassium, CEA, CA19.9 and Taurine.

The Prospect of Using Serum Taurine Level as a Potential Biomarker for Early Detection of Colorectal Carcinoma and Its Correlation With Other Prognostic Markers

Ain Shams University

Assistant Professor

Rare Diseases

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

Micronutrients

Capecitabine

Leucovorin

Fluorouracil

Tegafur

Oxaliplatin

Taurine + Sintilimab + XELOX or Taurine + Sintilimab + SOX or Taurine + Sintilimab + FOLFOX

Sintilimab + XELOX or Sintilimab + SOX or Sintilimab + FOLFOX

Taurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day. Frequency: 2 time/day.

Sintilimab

XELOX regimen

Oxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium)

SOX regimen

FOLFOX regimen

Xiaodi Zhao, MD, PhD

Xin Wang, MD, PhD

Jia Yu, MD

Yuanyuan Lu, MD, PhD

This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (sintilimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with sintilimab and chemotherapy alone.

Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer

A Prospective, Randomized Controlled Clinical Study of The Efficacy and Safety of Taurine Combined With Sintilimab and Chemotherapy Versus Sintilimab Combined With Chemotherapy for Treatment of Advanced Gastric Cancer

Changes in number, apoptosis rate, effector (TNF-α, IFN-γ, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of CD8+ T cells in peripheral venous blood assessed via flow cytometry.

Changes in number, effector (TNF-α, IFN-γ, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of tumor-infiltrating CD8+ T cells in gastric cancer endoscopic biopsy material assessed via immunohistochemistry.

PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on independent radiology review or death due to any cause, whichever occurs first.

OS was defined as the time from randomization to death due to any cause.

ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.

Number of study subjects experiencing adverse events (AEs), dose-limiting toxicities, and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.

Tang-Du Hospital

Adenocarcinoma

Docetaxel

Immunomodulating Agents

Taurine + Serplulimab + XELOX or Taurine + Serplulimab + FLOT

Serplulimab + XELOX or Serplulimab + FLOT

Serplulimab

Fluorouracil + leucovorin + oxaliplatin + docetaxel

FLOT regimen

This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (serplulimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with serplulimab and chemotherapy alone.

Prospective, randomized controlled clinical study

Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer

A Prospective, Randomized Controlled Clinical Study of The Efficacy and Safety of Taurine Combined With Serplulimab and Chemotherapy Versus Serplulimab Combined With Chemotherapy for Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

To evaluate the pathologic complete response rate of locally advanced gastric cancer treated with concurrent serplulimab with chemotherapy with or without taurine supplementation.

The surgical margin is microscopically-negative for residual tumor.

Residual tumor cells below 10% in the resected specimen.

DFS was defined as the time from surgery to postoperative recurrence or death from any cause, whichever occurred first. DFS was censored on the last tumor assessment date for patients still alive and without recurrence.

EFS was the time from enrollment to recurrence or death from any cause. EFS was censored on the last tumor assessment date for patients still alive and without recurrence.

OS was the time from enrolment to death from any cause. OS was censored on the last date known to be alive for patients without documentation of death.

Changes in number, effector (TNF-α, IFN-γ, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of tumor-infiltrating CD8+ T cells in gastric cancer endoscopic biopsy or surgical resection material assessed via flow cytometry and immunohistochemistry.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Assess Colonic Microbiota Changes in Response to Energy Drink Consumption	NCT06137248	Colorectal Canc...	Energy drink	18 Years - 40 Years	University of Florida
The Prospect of Using Serum Taurine Level as a Potential Biomarker for Early Detection of Colorectal Carcinoma and Its Correlation With Other Prognostic Markers	NCT04192539	Taurine in Canc...	Taurine	19 Years - 69 Years	Ain Shams University
The Prospect of Using Serum Taurine Level as a Potential Biomarker for Early Detection of Colorectal Carcinoma and Its Correlation With Other Prognostic Markers	NCT04192539	Taurine in Canc...	Taurine	19 Years - 69 Years	Ain Shams University
Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer	NCT06123455	Gastric Cancer	Taurine Sintilimab XELOX regimen SOX regimen FOLFOX regimen	18 Years -	Tang-Du Hospital
Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer	NCT06128252	Gastric Cancer	Taurine Serplulimab XELOX regimen FLOT regimen	18 Years - 75 Years	Tang-Du Hospital
Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer	NCT06123455	Gastric Cancer	Taurine Sintilimab XELOX regimen SOX regimen FOLFOX regimen	18 Years -	Tang-Du Hospital

Spots Global Cancer Trial Database for taurine

Every month we try and update this database with for taurine 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.

Spots Global Cancer Trial Database for taurine

Every month we try and update this database with for taurine 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.

Every month we try and update this database with for taurine 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.