Irritable Bowel Syndrome (IBS) Clinical Trial
Official title:
Intestinal Microbiome Fructan Metabolism and Symptom Generation in Childhood IBS
Verified date | January 2021 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates whether the gut microbiome is involved in determining whether children with irritable bowel syndrome (IBS) develop worsening GI symptoms (e.g. pain) when given fructans (a sugar often found in wheat). Participants will both receive a diet with fructans and a diet without fructans.
Status | Completed |
Enrollment | 55 |
Est. completion date | December 2019 |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 17 Years |
Eligibility | Inclusion Criteria: - Children ages 7-17 years - Children with IBS will meet Rome III criteria per the Rome III questionnaire - Healthy children will not have chronic conditions - English speaking and able to read/write in English Exclusion Criteria: - Previous bowel surgery - Documented gastrointestinal disorder (e.g. ulcerative colitis) - Serious chronic medical condition (e.g. diabetes) - Weight and/or height are greater than or less than 2 standard deviations for age - Chronic conditions with GI symptoms (e.g. cystic fibrosis) - Antibiotics within the past 3 months - Pregnancy - Autism spectrum disorder and/or significant developmental delay - Mood disorders (e.g. major depression) - Known post-infectious etiology |
Country | Name | City | State |
---|---|---|---|
United States | Children's Nutrition Research Center | Houston | Texas |
United States | Texas Children's Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Operational Taxonomic Units (microbiome composition derived from 16s rRNA sequencing) | Children with IBS who have worsening GI symptoms with fructans vs. those who do not | Three days | |
Primary | Microbiome metabolic signatures related to fructan metabolism | Children with IBS who have worsening GI symptoms with fructans vs. those who do not | Three days | |
Primary | Metabolic products of fructan metabolism | In those with IBS who have worsening symptoms when given fructans, the investigators will correlate fructan metabolic byproducts with GI symptoms (e.g. pain) | Three days | |
Secondary | Microbiome related signatures | Healthy children will have their microbiome signatures (composition, metabolic signatures related to fructan metabolism, and metabolic products of fructan metabolism) compared to children with IBS | Three days | |
Secondary | Overall microbiome metabolic signatures | Children with IBS who have worsening GI symptoms vs. those who do not | Three days | |
Secondary | Overall metabolic products | Following a fructan challenge in children with IBS who develop worsening GI symptoms vs. those who do not | Three days | |
Secondary | Breath hydrogen and methane production symptoms | Children with IBS who have worsening GI symptoms when given fructans vs. those who do not | Three days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT02841878 -
Genetic Determinism of Epithelial Barrier Defects in Irritable Bowel Syndrome
|
N/A | |
Completed |
NCT02875847 -
Effects of HMOs on Faecal Microbiota, Gastrointestinal Symptoms, Mucosal Immunity and Barrier Function in IBS Patients
|
Phase 2 | |
Completed |
NCT02092402 -
Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome
|
N/A | |
Completed |
NCT03964103 -
qQ-lab Daily-IBS for Irritable Bowel Syndrome
|
N/A | |
Completed |
NCT00401479 -
A Study To Investigate The Effect Of Solabegron (GW427353) On Gastrointestinal Transit In Healthy Volunteers
|
Phase 1 | |
Completed |
NCT00421707 -
Randomized Placebo Controlled Efficacy And Safety Study Investigating GW876008 In Patients With Irritable Bowel Syndrome
|
Phase 2 | |
Not yet recruiting |
NCT06139744 -
Efficacy and Safety of Dietary Supplementation of Diamine Oxidase to Improve Symptoms in Patients With IBS
|
Phase 4 | |
Recruiting |
NCT04506593 -
Indiana University Gastrointestinal Motility Diagnosis Registry
|
||
Completed |
NCT01908465 -
Peripheral Histamine 1 Receptor Blockade in IBS: Multicenter Trial
|
Phase 4 | |
Completed |
NCT01787253 -
Microbe-Gut Interaction in Microscopic Colitis and Post-Infectious Irritable Bowel Syndrome (IBS)
|
||
Completed |
NCT00376896 -
Study On The Effect Of GW876008 On Cerebral Blood Flow In Irritable Bowel Syndrome (IBS) Patients And Healthy Volunteers
|
Phase 1 | |
Completed |
NCT00904696 -
Tolerability and Effectiveness of Progut in Treatment of Irritable Bowel Syndrome
|
N/A | |
Recruiting |
NCT05453084 -
Exercise and Irritable Bowel Syndrome (IBS)
|
N/A | |
Completed |
NCT03550742 -
Effect of HMOs as Nutritional Support for Normal Bowel Movements in IBS Patients
|
N/A | |
Terminated |
NCT01887002 -
Study to Evaluate the Effects of ONO-2952 on Pain Perception Produced by Rectal Distention in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
|
Phase 2 | |
Completed |
NCT01774695 -
Physical Activity in IBS - a Long Term Follow up
|
N/A | |
Completed |
NCT01204515 -
Abdominal Symptom Phenotype Study in Children
|
N/A | |
Completed |
NCT00067457 -
Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy
|
Phase 3 | |
Completed |
NCT00067561 -
Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy
|
Phase 3 | |
Not yet recruiting |
NCT05630703 -
Mindfulness Training Versus Low (FODMAP) Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols Diet
|
N/A |