Microbiota Profiling in IBS

Irritable Bowel Syndrome Clinical Trial

— IBSQUtrition  

Official title:

Microbiota and Metabolite Profiles Linked to Severity in Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03720314
• Other study ID #: NL64950.081.18
• Status: Completed
• Start date: September 6, 2018
• Est. completion date: December 15, 2018

Study information

• Verified date: November 2018
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Rationale: Irritable Bowel Syndrome (IBS) is a gastro-intestinal disorder that strongly affects Quality of Life and impairs daily functioning. However, the aetiology and pathophysiology has been poorly understood. Studies suggest that intestinal microbiota in IBS is altered, however a general consensus remains elusive. This may be due to the large individual variation in microbiota and IBS symptoms, and the cross-sectional designs. Moreover, other factors like diet, wellbeing and metabolite profiles are often not taken into account. New evidence is suggesting that IBS severity may be an important factor in microbiota composition.

Objective: To determine faecal microbiota composition and metabolite production (such as acetate, propionate and butyrate), and investigate differences between healthy controls and mild or severe patients IBS. Moreover, to investigate whether (clinical) parameters such as symptom severity fluctuated, and if these fluctuations are associated with an alteration in faecal microbiota composition and metabolite production, one month after baseline, compared to healthy controls.

Study design: This study is a repeated cross-sectional study, with two data collection points (baseline, and after one month).

Study population: For this study, 100 IBS patients and 30 healthy controls will be recruited. After the first data collection point (T1), the 30 most mild and 30 most severe IBS patients will be included for data collection at T2 (after one month). All participants will be aged between 18 and 65 years.

Intervention (if applicable): Not applicable. Main study parameters/endpoints: primary endpoint of this study is microbiota composition and metabolite profiles, and the difference between groups and possible change after one month. These are assessed two faecal samples, which are analysed by 16S rRNA gene-based microbiota profiling. Secondary parameters are dietary intake, Quality of Life, depression and anxiety scores, and stool consistency and frequency, which are assessed by validated questionnaires.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 15, 2018
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Dietary Habits
• Infection
• Irritable Bowel Syndrome
• Microbial Colonization
• Syndrome

Intervention

Other:
• NA observational study
observational study

Locations

Country	Name	City	State
Netherlands	Wageningen University & Research	Wageningen	Gelderland

Sponsors (10)

Lead Sponsor	Collaborator
Wageningen University	Bioiberica, Darling, Ingredia, Naturex, Netherlands: Ministry of Health, Welfare and Sports, Nexira, Roquette Freres, Wecare, Winclove Bio Industries BV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in microbiota composition	microbiota composition will be measured in fecal samples, using 16S rRNA technique	baseline, and one month later
Primary	Change in Short chain fatty acid levels	Metabolite levels will be measured in fecal samples, using HPLC method	baseline, and one month later
Secondary	Dietary intake	Habitual dietary intake and habits will be measured using a Food Frequency Questionnaire.	baseline
Secondary	Change in Stool pattern	Using the bristol stool chart, and questions on frequency	baseline, and one month later
Secondary	Change in Gastro-intestinal complaints	will be measured using the validated questionnaire IBS-Symptom Severy Score (IBS-SSS). These results range from 0 - 500, and defines subjects in categories. <75 will be considered control/remission, 75-175 is considered mild complaints, 175-300 is considered moderate complaints, >300 is considered severe complaints. Based on results at baseline, the IBS group will be split into most mild and most severe IBS subjects.	baseline, and one month later
Secondary	Change in Anxiety and Depression screening scores	Using the questionnaire Hospital Anxiety and Depression Scale (HADS). Seperate scores for anxiety and depression will be calculated, ranging from 0 to 21. Subjects can be considered a "case" of depression and anxiety if scores are above 8.	baseline, and one month later
Secondary	Change in Quality of Life scores	The questionnaire IBS-Quality of life (IBS-QoL) will be administered, which calculates a score, ranging from 0 - 100. A higher score indicates a good quality of life.	baseline, and one month later