Clinical trials: Gut Function
Irritable Bowel Syndrome With Constipation
A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation
The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years.
- Trial name
- LIN-MD-63 (NCT02559817)
- Testing
- Linaclotide Dose A, Linaclotide Dose B, Linaclotide Dose C
- Where
- 48 sites in United States, Canada
- Volunteers
- 101 people
- Sponsor
- Forest Laboratories
Diarrhea-predominant Irritable Bowel Syndrome
Special Drug Use Surveillance of Irribow in Female Patients
The purpose of the survey is to evaluate the safety and efficacy of Irribow and Irribow OD Tablets in post-marketing medical practice and to examine the status of treatment compliance.
- Trial name
- NCT02612649
- Testing
- Ramosetron
- Where
- 34 sites in Japan
- Volunteers
- 793 people
- Sponsor
- Astellas Pharma Inc
CHAPLE Disease
A Study to Test the Safety of Pozelimab in Pediatric Participants 1 to 5 Years of Age With a Rare Disease Called CHAPLE (Complement Hyperactivation, Angiopathic Thrombosis, Protein-losing Enteropathy) Disease
This study is researching a drug called pozelimab (called "study drug"). The main aim of this study is to monitor the safety and tolerability of the study drug.
- Trial name
- NCT07142343
- Testing
- Pozelimab
- Where
- Turkey (Türkiye)
- Volunteers
- 5 people
- Sponsor
- Regeneron Pharmaceuticals
Functional Constipation, Irritable Bowel Syndrome With Constipation
Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)
The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (72 μg daily) in comparison with placebo in pediatric participants, 6 to 17 years of age, who fulfill modified Rome III Criteria…
- Trial name
- NCT04026113
- Testing
- Linaclotide
- Where
- 115 sites in United States, Belgium and 12 more
- Volunteers
- 438 people
- Sponsor
- AbbVie
Inflammatory Bowel Diseases, Irritable Bowel Syndrome
Fecal Calprotectin Collection Protocol
The primary objective is to obtain stool samples from subjects diagnosed with , and displaying signs and/or symptoms of IBD and/or IBS will be evaluated in this study.
- Conditions
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Ulcerative Colitis, Crohn Disease
- Trial name
- CALFE (NCT03143517)
- Testing
- Stool collection
- Where
- 13 sites in United States
- Volunteers
- 240 people
- Sponsor
- DiaSorin Inc.
Irritable Bowel Syndrome With Constipation, Functional Constipation
Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
LIN-MD-66 is a Phase 3 open-label study with 24 weeks (Functional Constipation participants) or 52 weeks (Irritable bowel syndrome with constipation participants) of linaclotide exposure that will enroll pediatric participants…
- Trial name
- NCT04166058
- Testing
- Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers), Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)
- Where
- 72 sites in United States, Canada and 2 more
- Volunteers
- 381 people
- Sponsor
- AbbVie
Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases), Irritable Bowel Syndrome With Constipation (IBS-C)
Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
The objective of this study is to evaluate the long-term safety and efficacy of linaclotide in post-marketing use.
- Trial name
- NCT03471728
- Testing
- linaclotide
- Where
- 47 sites in Japan
- Volunteers
- 2,475 people
- Sponsor
- Astellas Pharma Inc
Irritable Bowel Syndrome (IBS)
Irritable Bowel Syndrome Survey in Gastroenterological Adult Outpatients in China
The primary objective of this study is to estimate the overall prevalence of IBS medically diagnosed and diagnosed using Rome III or IV criteria in GI adult outpatients in China.
- Trial name
- IRONS (NCT02955316)
- Where
- China
- Volunteers
- 3,000 people
- Sponsor
- AstraZeneca
Crohn's Disease
Long-term Safety Study of Brodalumab in Adults With Crohn's Disease
The purpose of this study is to evaluate the safety and efficacy of long-term treatment with brodalumab in adults with Crohn's disease.
- Trial name
- NCT01199302
- Testing
- Brodalumab
- Where
- 34 sites in United States, Australia and 6 more
- Volunteers
- 67 people
- Sponsor
- Amgen
Functional and Motility Related Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional Dyspepsia
A Pharmacy-based Study to Learn More About How Well Iberogast Works, How it Affects the Body, How it is Used, and User Satisfaction in Patients With Functional and Motility-related (Stomach and Bowel Movement-related) Gastrointestinal Diseases, Including Irritable Bowel Syndrome
Researchers want to learn more about the day-to-day use of Iberogast in people who have functional and motility-related gastrointestinal (stomach and bowel) diseases.
- Trial name
- NCT04993989
- Testing
- Iberogast (STW5, BAY98-7411)
- Where
- Germany
- Volunteers
- 843 people
- Sponsor
- Bayer
Irritable Bowel Syndrome
Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children
The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating irritable bowel syndrome with diarrhea (IBS-D) in pediatric participants 6-17 years of age, to evaluate the pharmacokinetics of…
- Trial name
- NCT03339128
- Testing
- Eluxadoline
- Where
- 46 sites in United States, Bulgaria and 7 more
- Volunteers
- 272 people
- Sponsor
- AbbVie
Irritable Bowel Syndrome
A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
This study will assess the long-term safety of oral Eluxadoline administered to pediatric participants with IBS-D who have completed study intervention in the Phase 2 study 3030-202-002 or the Phase 3 study 3030-303-002.
- Trial name
- NCT04880876
- Testing
- 25mg Eluxadoline, 100mg Eluxadoline
- Where
- 6 sites in United States
- Volunteers
- 124 people
- Sponsor
- AbbVie
Functional Gastrointestinal Disorders (FGIDs), Weight Loss
Effects of Multi-strain Bacillus Spore Probiotics on Growth, Digestive Function, and Gut Microbiota in Cesarean-Delivered Neonates
Infants born by cesarean section commonly show early weight loss and slower recovery of birth weight, together with characteristic patterns of gut microbiota dysbiosis marked by reduced Bifidobacterium and Bacteroides and…
- Trial name
- NCT07320287
- Testing
- RO water, LiveSpo PREG-MOM, LiveSpo CONSY
- Where
- Vietnam
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Anabio R&D
Crohn's Disease
A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies…
- Trial name
- NCT02641392
- Testing
- GED-0301
- Where
- 231 sites in United States, Australia and 29 more
- Volunteers
- 310 people
- Sponsor
- Celgene
Gut Inflammation
A1 Versus A2® Milk on the Gastrointestinal Physiology, Symptoms and Cognitive Behaviour for the Preschool Children
This is a multiple-sites, double-blinded, randomized, controlled, parallel-designed, cross-over study among healthy preschoolers with 5 days consumption of A2 or A1 milk to compare the effects on gut inflammation…
- Trial name
- NCT03081845
- Testing
- Oral consumption of milk A1 in study phase 1, Oral consumption of milk A2 in study phase 1, Oral consumption of milk A1 in study phase 2
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- a2 Milk Company Ltd.
Infantile Colic, Constipation
Randomized Placebo-controlled Study of L. Reuteri NCIMB 30351 in GI Functional Disorders and Food Allergy in Newborns
This study is a randomized, placebo-controlled, single-masked (blinded), post-marketing clinical study of a drug Lactobacillus Reuteri NCIMB 30351 drops in functional disorders of gastrointestinal tract and skin symptoms of food…
- Conditions
- Infantile Colic, Constipation, Infantile Diarrhea, Gastro Esophageal Reflux
- Trial name
- NCT04262648
- Testing
- Lactobacillus Reuteri
- Where
- 2 sites in Russia
- Volunteers
- 90 people
- Sponsor
- NovoNatum Ltd
Infant Growth
Growth and Health Efficacy of Novel Infant Formula : A Randomized Trial
Randomized, controlled study consisting of three parallel arms to investigate the effects of novel infant formula on growth, gut health, immune function, and sleep status in healthy infants and young children aged 12-18 months.
- Trial name
- NCT07534735
- Testing
- Investigational Formula 1, Investigational Formula 2
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Biostime (Changsha) Nutrition Foods Limited
Constipation - Functional
Effect of a Mixture of Fibers and Carbohydrates on Intestinal Transit in Children Diagnosed With Functional Constipation
Once the patients who are candidates to enter the study are identified, the patients will be randomly be assigned to two groups, according to the sequence: Group A: study product+wash out+control product Group B: control…
- Trial name
- VEGY-DOWN(A) (NCT04028258)
- Where
- 3 sites in Spain
- Volunteers
- 120 people
- Sponsor
- Laboratorios Ordesa
Functional Gastrointestinal Disorders
Study to Learn More About the Stomach and Intestine Complaints of Children Aged From 3 to 14 Years
In this observational study, researchers want to gain more information on children suffering from abnormal stomach and intestine function (based on the Rome criteria) and treated Iberogast.
- Trial name
- NCT04029376
- Testing
- Iberogast®
- Where
- Germany
- Volunteers
- 1,032 people
- Sponsor
- Bayer
IBD (Inflammatory Bowel Disease), IBS (Irritable Bowel Syndrome)
Specimen and Data Collection for a Novel Biomarker Combination for the Differential Diagnosis of Inflammatory Bowel Disease and Irritable Bowel Syndrome.
This study will evaluate how well the a new stool test can distinguish inflammatory bowel disease (IBD) from non-IBD conditions compared with standard calprotectin testing and colonoscopy findings.
- Conditions
- IBD (Inflammatory Bowel Disease), IBS (Irritable Bowel Syndrome), Gastrointestinal Symptoms
- Trial name
- COMBI (NCT07471490)
- Where
- 2 sites in United States, Italy
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- DiaSorin Inc.