The objective of this study is to assess the effect of galacto-oligosaccharides (Biotis* GOS Omni powder) on the number of bowel movements in an adult population with self-reported constipation.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Self-reported stool frequency, assessed weekly, in weekly in online
questionnaires
Secondary outcome
Self-reported stool consistency, assessed weekly in online questionnaires with
the Bristol 7-point stool scale.
Background summary
Constipation is one of the most common health impairments in the Western
countries which can severely affect the individual*s quality of life and
general well-being.
The current interventions for constipation include lifestyle and dietary
modifications as well as pharmacological interventions with stool softeners,
osmotic laxatives, and stimulant laxatives. Dietary modifications include an
increased intake of fibre-rich fruits and vegetables together with a sufficient
intake of water. In addition to those modifications, supplementation with
dietary fibres may be considered to reduce symptoms of constipation.
FrieslandCampina has identified a specific galacto-oligosaccharide mixture that
may affect stool characteristics and thereby may reduce symptoms of
constipation. The aim of the present study is to investigate the effect of
galacto-oligosaccharides in a dose of 5,5 gram or 11 gram per day on stool
characteristics, microbiota composition and quality of life in adults with
self-reported constipation.
Study objective
The objective of this study is to assess the effect of
galacto-oligosaccharides (Biotis* GOS Omni powder) on the number of bowel
movements in an adult population with self-reported constipation.
Study design
The TRANSIT study is a randomized, double-blind, placebo-controlled, parallel
intervention study in 132 healthy adults with self-reported constipation. The
study will include 3 arms; 5.5 gr and 11 gr galacto-oligosaccharides and a
control product. After a baseline week, all subjects will be included in a 3,5
week intervention period, including a 4 day run-in period to get familiarized
with the study product.
Intervention
The subjects, divided in 3 study groups (44 persons each) will consume either
one of the interventions:
GOS: Biotis* GOS Omni powder, containing 15.1 gr powder with 11 gr active GOS
(once per day)
GOS: Biotis* GOS Omni powder, containing 7.5 gr powder with 5.5 gr active GOS
(once per day)
Control (placebo): 15.1 gr of Maltodextrin (once per day) maltodextrin.
Study burden and risks
Study subjects, using laxatives, will be asked to stop with the use since this
will interfere with the study outcome. Stopping might induce intestinal
complaints. When the complains become too painful the use of one enema/ week is
allowed. If the enema does not result in relief within 24 hours the use of a
laxative is allowed, the study subject will be taken out of the PP group of the
study.
The intake of GOS might cause flatulence and bloating at the onset of the
treatment. To reduce/ avoid this effect a run-in period of 4 days, in which the
amount of the test product is gradually increased, is included in the study
setup.
The subjects are asked to complete weekly questionnaires and collect a faecal
sample at the start and at the end of the study.
Bronland 20
Wageningen 6709 WH
NL
Bronland 20
Wageningen 6709 WH
NL
Listed location countries
Age
Inclusion criteria
Males and females
Age * 18 years
BMI *18,5 and * 28,0 kg m2.
Healthy as assessed by the NIZO health questionnaire
Self-reported constipation according to the Rome IV criteria with the following
criteria (for the last 3 months):
Fewer than three (3) bowel movements per week.
And one or more of the criteria below:
* Straining during at least 25% of all defecations
* Lumpy or hard stools (BSFS 1-2) in at least 25% of defecations,
* Sensation of incomplete evacuation for at least 25% of defecations,
* Sensation of anorectal obstruction/blockage for at least 25% of defecations,
* Manual manoeuvres to facilitate at least 25% of defecation (e.g., digital
evacuation, support of the pelvic floor)
*Willingness to abstain from laxatives during the study
Exclusion criteria
- Major abdominal surgery interfering with GI function
- Major co-morbidities,such as diagnosed inflammatory bowel disease, diagnosed
celiac disease, diagnosed diverticulitis, a history of gastrointestinal tumors
and other unforeseen co-morbidities, that may have an impact on the study
results (as decided by the medical investigator)
- Use of medication that may affect the results of the investigational product,
such as physician prescribed laxatives, and medication that influences the
motility of the GI tract
-Use of antibiotics 90 days before the start of the study
-Use of strict diets (Vegan diet, gluten free diet, or crash-diet with use of
meal replacers)
-Self-reported lactose-intolerance
- Self reported cow's milk allergy
- Diagnosed diabetes
-Pregnant and lactating women
-Expected change in lifestyle within 14 days before and during the trial period
(i.e. diet, physical activity, smoking, alcohol consumption and medication
use)
-History of side effect with the use of prebiotic supplements
-Use of alcoholic beverages for men > 28 units/week and >4/day; for women: >21
units/week and >3/day
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 | NL73442.028.20 |