The primary objective is to determine the effects of a 4-week intervention with either a prebiotic supplement (Inavea pure acacia) or a probiotic supplement (Bifidobacterium lactis BLa80) on stool pattern (including stool frequency, consistency, and…
ID
Source
Brief title
Condition
- Food intolerance syndromes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is stool pattern: stool frequency, stool
consistency and stool volume.
Secondary outcome
The secondary study parameters are gastrointestinal complaints, Quality of
Life, and HADS.
Background summary
Irritable Bowel Syndrome (IBS) is a disease 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 stool pattern in
IBS-Constipation (IBS-C) patients.
Study objective
The primary objective is to determine the effects of a 4-week intervention with
either a prebiotic supplement (Inavea pure acacia) or a probiotic supplement
(Bifidobacterium lactis BLa80) on stool pattern (including stool frequency,
consistency, and volume) in IBS-C patients. The secondary objective is to
determine the effects of this 4-week intervention on GI complaints and quality
of life in IBS-C patients.
Study design
A double-blind, randomized, placebo-controlled trial will be conducted with
three parallel intervention arms
Intervention
A 4 week run-in period will be followed by a 4-week intervention period with
three parallel arms: 1) prebiotic supplement (Inavea pure acacia), 2) probiotic
supplement (B. lactis), and 3) 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 14.5 hours of their time in this study
mainly to complete several questionnaires (short daily questionnaire, longer
questionnaires at three occasions), which is conveniently all possible from
home. They have to comply to consume a supplement twice daily for four weeks.
At two time points, they have to collect their stool for five days. 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 + additional criteria specific
for the constipation-predominant subtype.
* Male and female adults, aged 18-70 years.
* Have a Body Mass Index (BMI) between 18.5 and 30 kg/m2 (self-reported).
* Willing to keep a stable dietary pattern throughout the study.
* Having a smartphone to fill out the daily questionnaires
Exclusion criteria
* Having a disease that may interfere with the outcomes of this study,
such as a known autonomic disorder, inflammatory bowel disease, coeliac
disease, cancer, dialysis patients, chronic kidney failure, depression or
hypothyroidism.
* History of intestinal surgery (excluding appendectomy or cholecystectomy) or
endometriosis.
* Use of medication that can interfere with the study outcomes, including
antidepressants (allowed when it is not subscribed for mental depression),
codeine, and antibiotics, as judged by the medical supervisor MD Ben Witteman.
* Use of prescribed laxatives. Over-the-counter laxatives are allowed, but
intake should be either stopped before the start of the study or kept stable
during the complete study period.
* Use of prebiotics and/or probiotics (should be stopped 4 weeks before the
start of the study) and infrequent use of other (fiber) supplements dedicated
to bowel function improvements. 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).
* If applicable: currently pregnant or breastfeeding, or intending to become
pregnant during the study, as this can affect stool pattern and wellbeing.
* Participation in another clinical trial at the same time.
* Student or employee working at Food, Health and Consumer Research from Food
and Biobased Research, or Department of Human Nutrition & Health, Wageningen
University.
* Alcohol intake * 2 (women) or * 4 (men) glasses of alcoholic beverages per
day.
* Abuse of illicit drugs, soft drugs, and nitrous oxide.
* Smoking
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 | NL76449.041.21 |
| Other | volgt nog |