Clinical trials: Gastrointestinal Tolerance
Gastrointestinal Discomfort, Performance Status
A Safety/Tolerance Phase, Ascending Single Dose Study to Evaluate the Safety and Tolerability of G3P-01, a Food-Grade Pectic Product, in Healthy Volunteers
This is an interventional, open-label study to evaluate the safety, tolerability and PK of escalating single doses of G3P-01 in 10 healthy adult subjects.
- Trial name
- G3P-01-01 (NCT05296083)
- Testing
- G3P-01
- Where
- Netherlands
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- SQ Innovation, Inc.
Enteral Feeding
Nutritional Tolerance and Safety of a Tube Feeding Formula
This open-label, prospective study will be conducted to assess the nutritional efficacy, safety, and tolerance of a concentrated, enteral formula in medically stable adults, who currently require or will require to be enterally…
- Trial name
- NCT05848583
- Testing
- Compleat 1.5
- Where
- Canada
- Volunteers
- 3 people
- Sponsor
- Société des Produits Nestlé (SPN)
Colorectal Cancer
A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal Cancer
This study was designed to investigate the safety and tolerance of three doses (100µg, 200µg, 500µg) of G17DT for the treatment of patients with colorectal cancer.
- Trial name
- CC1C (NCT02228785)
- Testing
- G17DT
- Volunteers
- 5 people
- Sponsor
- Cancer Advances Inc.
Regurgitation, Gastric
Evaluation of the Tolerance and Safety of a New Partly Fermented Anti-regurgitation Infant Formula
A randomised, controlled, double-blind trial to evaluate the tolerance and safety of a new partly fermented anti-regurgitation infant formula containing prebiotics and locust bean gum in infants with regurgitation.
- Trial name
- Leopard (NCT03371615)
- Testing
- Anti-regurgitation infant formula
- Where
- 2 sites in Poland
- Volunteers
- 182 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Dysphagia
Acceptability and Tolerance Study of a Thickener
This is a prospective, acceptability study to evaluate the gastrointestinal tolerance and compliance of a thickener for the management of reflux, GORD and dysphagia
- Trial name
- NCT05026476
- Testing
- Resource Thicken up Junior
- Where
- United Kingdom
- Volunteers
- 21 people
- Sponsor
- Société des Produits Nestlé (SPN)
Cervical Cancer, Head and Neck Squamous Cell Carcinoma
HRYZ-T101 TCR-T Cell for HPV-18 Positive Advanced Solid Tumor
A single center, open, single arm dose escalation phase I study to evaluate the safety, tolerability, and efficacy of HRYZ-T101 TCR-T cell for HPV18 positive advanced solid tumor.
- Conditions
- Cervical Cancer, Head and Neck Squamous Cell Carcinoma, Oropharyngeal Cancer, Vagina Tumor
- Trial name
- NCT05787535
- Testing
- Fludarabine + Cyclophosphamide, HRYZ-T101 TCR-T Cell
- Where
- China
- Volunteers
- 17 people
- Sponsor
- HRYZ Biotech Co.
Critically Ill
Pilot Study on Gastro-intestinal (GI) Enteral Nutrition (EN) Tolerance in Intensive Care Unit Patients
Specifically designed enteral formulations may improve the gastrointestinal tolerance during early enteral nutrition in the critically ill patient.
- Trial name
- SPIRIT (NCT01581957)
- Testing
- Specific Enteral Nutrition, Standard Enteral Nutrition
- Where
- Switzerland
- Volunteers
- 90 people
- Sponsor
- Société des Produits Nestlé (SPN)
Growth, Tolerance
Human Milk Oligosaccharides (HMOs) Post-market Study on Infants (NEHMO)
Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT).
- Conditions
- Growth, Tolerance, Adverse Event, Disorder of Intestine
- Trial name
- NeHMO DACH (NCT05150288)
- Testing
- HMO-supplemented infant formula
- Where
- 17 sites in Austria, Germany and 1 more
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Metastatic Pancreatic Ductal Adenocarcinoma
A Study of the Safety and Tolerance of CAN04 in Combination With FOLFIRINOX in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma
This study will consider the safety and effectiveness of a study drug, CAN04, in combination with FOLFIRINOX, in the treatment of metastatic pancreatic ductal adenocarcinoma.
- Trial name
- CAPAFOUR (NCT04990037)
- Testing
- CAN04, FOLFIRINOX
- Where
- 9 sites in France, Spain
- Volunteers
- 25 people
- Sponsor
- Cantargia AB
Gastrointestinal Tolerance, Healthy Population
Evaluating the Impact of Fat and Sugar Replacer Blends on Gastrointestinal Tolerance in Biscuits
This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance and bowel habits of sugar- and fat- replacer ingredients and blends (maltitol, polydextrose, allulose and EPG)
- Trial name
- NCT07372482
- Testing
- Test sandwiched biscuits with creme, Control sandwiched biscuit with sugar
- Where
- Canada
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Mondelēz International, Inc.
Gastroesophageal Reflux
Study on the Tolerance and Efficacy of a New Anti Regurgitation Formula
The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation.
- Trial name
- SONAR (NCT02425423)
- Testing
- New thickened formula
- Where
- 3 sites in Belgium, France
- Volunteers
- 100 people
- Sponsor
- United Pharmaceuticals
Nutrition Disorders
Acceptability and Tolerance Study of a Plant-based Tube Feed
This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a 7-day period with a plant based tube feed.
- Trial name
- NCT06209593
- Testing
- Compleat plant protein tube feed
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Société des Produits Nestlé (SPN)
Dietary Exposure
Acceptability and Tolerance Study of Peptide Feed with Fibre
Enterally fed adults with documented evidence of gastrointestinal intolerance will be recruited. Participants will be deemed by the investigator as having a clinical indication for enteral feeding with a fibre containing peptide…
- Trial name
- NCT06102135
- Testing
- Peptamen 1.3 PHGG
- Where
- 2 sites in United Kingdom
- Volunteers
- 15 people
- Sponsor
- Société des Produits Nestlé (SPN)
Paediatrics
Acceptability, Gastrointestinal Tolerance, Compliance and Palatability Study.
Acceptability, compliance and palatability study.
- Trial name
- NCT07210658
- Testing
- Oral nutritional supplementation
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- Société des Produits Nestlé (SPN)
Non-Alcoholic Fatty Liver Disease
Effects of TOTUM-448 on Liver Fat Content, Cardiometabolic Risk Factors and Gut Microbiota Among Participants with MASLD
This clinical trial aims to investigate the effects of TOTUM-448, a mix of 5 plant extracts and choline, consumed at the daily regimen of two times per day, on liver fat content, cardiometabolic risk factors and gut microbiota…
- Trial name
- CARDIO-LIVER (NCT06704321)
- Testing
- TOTUM-448
- Where
- Canada
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Valbiotis
Gastrointestinal Tolerance of Dietary Fiber
Fiber Tolerance Study
Research shows that many people do not get enough dietary fiber through their normal diet. As a result, some nutrients are not properly absorbed into the bloodstream. The immune system however does need these nutrients.
- Trial name
- Gitomix (NCT06115057)
- Testing
- Fiber
- Where
- Netherlands
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Advanced or Metastatic Gastric Cancer, Advanced or Metastatic Liver Cancer
Study of Metatinib Tromethamine Tablet
This is an open-label, multicenter study designed to assess the safety, tolerability, preliminary efficacy and pharmacokinetics of Metatinib Tromethamine tablet in patients with advanced or metastatic gastric cancer, liver…
- Conditions
- Advanced or Metastatic Gastric Cancer, Advanced or Metastatic Liver Cancer, Advanced or Metastatic CRC, Advanced or Metastatic Non Squamous NSCLC
- Trial name
- NCT02650375
- Testing
- Metatinib Tromethamine
- Where
- 3 sites in China
- Volunteers
- 24 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Growth
Evaluation of Safety, Growth, Tolerance and Effects on the Intestinal Fora of a New Milk for Healthy Infants
The purpose of the study is to assess growth and tolerance in new born and infant fed an experimental infant formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic.
- Trial name
- Pétunia (NCT00920166)
- Testing
- Pétunia 1, Regular formula
- Where
- 4 sites in France
- Volunteers
- 97 people
- Sponsor
- Sodilac