Microbiota Profiling in IBS

NCT03720314 | Completed

• 1 other identifier: NL64950.081.18
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates differences in microbiota profiles and metabolite levels between mild and severe IBS patients, compared to matched healthy controls. Two fecal samples, with one month in between, will be analyzed. Secondary parameters such as dietary intake, quality of life and stool pattern will be assessed.

Conditions

Irritable Bowel Syndrome; Microbial Colonization; Dietary Habits

Outcome Measures

Primary Outcomes (2)

• Change in microbiota composition

  microbiota composition will be measured in fecal samples, using 16S rRNA technique

  baseline, and one month later

• Change in Short chain fatty acid levels

  Metabolite levels will be measured in fecal samples, using HPLC method

  baseline, and one month later

Secondary Outcomes (5)

• Dietary intake

  baseline

• Change in Stool pattern

  baseline, and one month later

• Change in Gastro-intestinal complaints

  baseline, and one month later

• Change in Anxiety and Depression screening scores

  baseline, and one month later

• Change in Quality of Life scores

  baseline, and one month later

Study Arms (2)

IBS

Irritable bowel syndrome patients

Other: NA observational study

control

healthy controls

Other: NA observational study

Interventions

NA observational study OTHER

observational study

IBS; control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

100 IBS patients, and 30 healthy matched controls. After baseline measurements, the 30 most mild IBS and 30 most severe IBS will be follow-up one month later. n=40 IBS drops out after baseline. Healthy controls will be matched with mild IBS patients, based on age, gender and BMI.

You may qualify if:

• IBS patients that meet the Rome IV criteria, or healthy subjects with no gastro-intesitnal complaints
• In close proximity of Wageningen (max. 50 km)
• Signed informed consent.
• After baseline measurements, IBS severity will be checked using the IBS-SSS. Participants will be included for follow-up one month later, when they have the most mild symptoms (n=30) or most severe (n=30) symptoms.

You may not qualify if:

• Presence of gastro-intestinal diseases, such as celiac disease, Crohn's disease, or Ulcerative colitis.
• Have a history of intestinal surgery that might interfere with study outcomes. This does not include an appendectomy or cholecystectomy.
• Presence of significant systemic diseases, such as diabetes mellitus, cancer, cardiovascular disease or respiratory disease.
• Female participants: currently pregnant or breast-feeding.
• Use of antibiotic treatment less than 3 months before start of the study and no use of antibiotics during the study.
• You are participant in another study during this study.
• Are an employee or student of the Division of Human Nutrition, Food and Biobased Research or Laboratory of Microbiology, of Wageningen University \& Research.
• Unwilling or unable to fulfil study criteria.
• If they are not selected in the most mild or most severe group after T1.

Sponsors & Collaborators

• Wageningen University: lead
• Netherlands: Ministry of Health, Welfare and Sports: collaborator
• Ingredia S.A.: collaborator
• Nexira: collaborator
• Naturex: collaborator
• Bioiberica: collaborator
• Wecare: collaborator
• Roquette Freres: collaborator
• Darling: collaborator
• Winclove Bio Industries BV: collaborator

Study Sites (1)

Wageningen University & Research

Wageningen, Gelderland, 6708WE, Netherlands

Location

Related Publications (1)

• Wang T, van Dijk L, Rijnaarts I, Hermes GDA, de Roos NM, Witteman BJM, de Wit NJW, Govers C, Smidt H, Zoetendal EG. Methanogen Levels Are Significantly Associated with Fecal Microbiota Composition and Alpha Diversity in Healthy Adults and Irritable Bowel Syndrome Patients. Microbiol Spectr. 2022 Dec 21;10(6):e0165322. doi: 10.1128/spectrum.01653-22. Epub 2022 Nov 2.

  PMID: 36321894 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Subjects will hand in fecal samples for microbiota composition analysis, which will be done using 16r RNA technique.

MeSH Terms

Conditions

Irritable Bowel Syndrome; Communicable Diseases; Feeding Behavior

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Ben Witteman, Prof MD PhD

  Wageningen University & Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: October 25, 2018
• Study Start: September 6, 2018
• Primary Completion: December 15, 2018
• Study Completion: December 15, 2018
• Last Updated: February 21, 2019

Record last verified: 2018-11

Locations

NL (1)