The primary objective is to determine the bifidogenic effects of a 4-week intervention with one of four dietary supplements (Chondroitin sulfate, NOVELOSE® 3490, and Pea Fiber, and Lactium®) in IBS patients. The secondary objective is to determine…
ID
Source
Brief title
Condition
- Food intolerance syndromes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the (relative) abundance of fecal Bifidobacterium.
Secondary outcome
The secondary study parameters are fecal microbiota composition, fecal SCFAs,
stool frequency and consistency, IBS-related complaints, and Quality of Life.
Background summary
Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disorder that
affects a large number of people. To date, no adequate treatment is available.
This is partially due to the heterogeneity of the patients and the complicated
pathology in which not all mechanisms are understood.
Based on results of in vitro screening within the IBSQUtrition project, we
selected promising dietary supplements for validation of their potential
beneficial effects on the microbiota of IBS patients.
Study objective
The primary objective is to determine the bifidogenic effects of a 4-week
intervention with one of four dietary supplements (Chondroitin sulfate,
NOVELOSE® 3490, and Pea Fiber, and Lactium®) in IBS patients. The secondary
objective is to determine the effects this 4-week intervention on fecal
microbiota profiles, SCFAs, IBS-related complaints, Quality of Life, and stool
frequency and consistency in IBS patients.
Study design
A double-blind, randomized, placebo-controlled trial with five parallel arms
Intervention
4-week intervention period with five parallel arms: 1) Chondroitin sulfate, 2)
NOVELOSE® 3490, 3) Pea Fiber, 4) Lactium®, and 5) Placebo supplement
(Maltodextrin control), during which the study participants consume the
respective supplement twice per day.
Study burden and risks
Study participants have to invest about 7.4 hours of their time in this study
mainly to complete several questionnaires (short daily questionnaire, longer
questionnaires at two occasions), which is conveniently all possible from home.
At two occasions they have to collect stool (transported via courier to the
research facility). They have to comply to consume a commercially available
supplement twice daily for four weeks. There are limited risks for the study
participants.
Bornse Weilanden 9
Wageningen 6708 WG
NL
Bornse Weilanden 9
Wageningen 6708 WG
NL
Listed location countries
Age
Inclusion criteria
- IBS patients that meet the Rome IV criteria. This will be evaluated by the
medical supervisor;
- Male and female adults, aged 18-65 years;
- Having a Body Mass Index (BMI) between 18.5 and 30 kg/m2;
- Willing to keep a stable dietary pattern throughout the study;
- Having a smartphone to fill out the daily questionnaires;
Exclusion criteria
- Having a gastro-intestinal disease, such as celiac disease, Crohn*s disease,
or Ulcerative colitis;
- Having a history of intestinal surgery that might interfere with study
outcomes. This does not include an appendectomy or cholecystectomy;
- Having a food allergy to milk protein or pulse protein;
- Presence of significant systemic diseases, such as diabetes mellitus, cancer,
cardiovascular disease or respiratory disease;
- When applicable: currently pregnant or breastfeeding, or intending to become
pregnant during the study, as this can affect stool patterns and wellbeing;
- Use of antibiotic treatment less than 3 months before start of the study and
no use of antibiotics during the study;
- Use of prebiotics and/or probiotics (should be stopped 4 weeks before the
start of the study) and infrequent use of other (fiber) supplements. Some
supplements are allowed, but intake should be kept stable during the whole
study period (Supplements will be judged by the medical supervisor MD Ben
Witteman);
- Currently following a FODMAP-restricted diet;
- Use of medication that can interfere with the study outcomes, including
anxiolytics (antidepressants are allowed), laxatives (Over-the-counter
laxatives are allowed, but intake should be either stopped at least 4 weeks
before the start of the study or kept stable during the complete study period),
and codeine, as judged by the medical supervisor MD Ben Witteman;
- Participation in another clinical trial at the same time;
- Student or employee working at Food, Health and Consumer Research from
Wageningen Food and Biobased Research;
- Alcohol intake * 2 (women) or * 4 (men) glasses of alcoholic beverages per
day;
Abuse of illicit drugs
- being incapacitated
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75824.041.20 |
| Other | volgt nog |