The objective of this clinical trial is to evaluate the tolerance and effectiveness of 4 week supplementation of a proprietary polydextrose fiber product, in a dose-ranging fashion, on whole gut transit time and gastrointestinal symptoms in adults…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate change in whole gut transit time at the mid-consumption period
timepoint (+2 weeks) in constipated patients consuming the study food product
containing fiber in high quantity (Group 1), compared to those consuming
placebo (Group 3).
Secondary outcome
• Assess change in gastrointestinal symptoms during the consumption period of
the study food product
• Assess tolerance to the study food product
• Evaluate physiological and symptomatic endpoint(s) that best correlate with
gut transit time
• Evaluate changes in regional (right colon, left colon, and rectosigmoid)
colonic transit times at the mid-consumption period timepoint (+2 weeks)
• Evaluate change in whole gut transit time at the mid-consumption period
timepoint (+2 weeks) in constipated patients consuming the study food product
containing fiber in low quantity (Group 2), compared to those consuming placebo
(Group 3)
Background summary
Gastrointestinal (GI) discomfort regularly affects >25% of the population
worldwide. One of the major contributors to GI discomfort is constipation,
which has a prevalence of ~15% (McCrea et al, 2008), and symptoms of which have
a significant negative impact on the sufferer*s quality of life. The management
of constipation remains challenging, with a high economic impact on the Dutch
Health Insurance system. In 2013 within the Netherlands a total of ¤ 48 million
was spent on medication for the treatment of obstipation, this was for just
over 1 million patients using these type of drugs. Only a minority of patients
consult a physician for these complaints, , thus there is a huge unmet need for
food-based alternatives to the currently available prescription and over the
counter laxatives and supplements in symptom management.
Dietary fiber supplements are widely used as a first-line treatment for
constipation although little evidence exists to support its use in adults. The
effectiveness of different fiber supplements is difficult to compare given wide
differences in water-retention capabilities and effects on the colonic
microbial ecology. Polydextrose is a type of soluble fiber that is partially
fermented by the gut microbiota with a resulting increase in stool bulk and
frequency as well as improved stool consistency and easier defecation.Because
of these attributes, polydextrose is hypothesized to have benefit in people with
constipation.
Study objective
The objective of this clinical trial is to evaluate the tolerance and
effectiveness of 4 week supplementation of a proprietary polydextrose fiber
product, in a dose-ranging fashion, on whole gut transit time and
gastrointestinal symptoms in adults with functional constipation.
Study design
This will be a randomised, double-blind, , parallel study of three groups:
Group 1: food product containing polydextrose in high quantity; Group 2: food
product containing plydextrose in low quantity; Group 3: placebo.
• Study group 1: low high quantity fiber containing product
• Study group 2: high low quantity fiber containing product
• Study group 3: placebo
Intervention
The patients need to take twice a day one sachet during four weeks. The powder
in the sachet needs to be mixed with 200ml of water.
• Study group 1: low high quantity fiber containing product (6g/sachet)
• Study group 2: high low quantity fiber containing product (4g/sachet)
• Study group 3: placebo
Study burden and risks
The patients need to visit four times within a period of four weeks. During two
visit a fluoroscopic investigation will take place. For this patients need to
take one radio-opaque capsule per day during six days before the investigation.
During the four weeks the patients need to maintain a diary and complete
several questionnaires.
Avenue Nestle 55
Vevey CH-1800
CH
Avenue Nestle 55
Vevey CH-1800
CH
Listed location countries
Age
Inclusion criteria
• Adult men or women (female subjects of child-bearing potential must be willing to use a reliable method of contraception throughout the study period)
• Age 18 - 75
• BMI: 18.5 - 29.9 kg/m2
• Symptoms of constipation for a minimum of 3 months
• Recruitment based on simplified core ROME III diagnostic criteria for functional constipation (based on specific screening questions):
o average Bristol stool type of 1 - 3 AND frequency of 1 - 3 spontaneous bowel movements (SBMs) per week
o plus at least ONE of the following at screening:
* straining on at least 25% of defaecations
* sensation of incomplete evacuation on at least 25% of defaecations
* sensation of anorectal obstruction / blockage on at least 25% of defaecations
* use of manual manoeuvres on at least 25% of defaecations.
• Cleveland Clinic constipation score (CCCS) of 8-20
• Low-moderate fibre intake (<=18g) determined by the semi-quantitative food intake screener known as the Block Fibre Screener
• Ability to understand the patient information sheet and instructions in Dutch, and able to provide informed consent
Exclusion criteria
• Subjects who report lactose intolerance and/or are allergic to soy or cow milk protein
• Pregnant or breast-feeding women
• Ongoing other diagnosed gastrointestinal disease or complication (Crohn's disease, Coeliac disease, chronic diarrhoea)
• Any clinical relevant abnormalities in the screening visit medical examination or alarm features such as sudden unintentional weight loss, rectal bleeding, recent change in bowel habit (<3 months), abdominal pain and stool positive for occult blood
• Prior abdominal surgery (including gastric bypass or laparoscopic banding), except cholecystectomy and appendicectomy
• Neurologic diseases such as multiple sclerosis, stroke, spinal cord injury, Hirschsprung disease
• Chronic medication that in opinion of the investigator would impact gut motility
• Illness that may preclude the subject's ability to complete the study or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness, severe cardiovascular disease, chronic renal failure or eating disorders) or any other serious illness resulting in >2 weeks inability to work in the 3 months before the study start
• Subjects with co-morbid illnesses such as cardiovascular, endocrine, renal or other chronic disease likely to affect gut motility or limit normal functions (e.g. reduced mobility or increased fragility)
• Ongoing alcohol, drug, or medication abuse (anamnesis only)
• Self-reported symptoms of pelvic organ prolapse
• Moderate or severe active local anorectal problems such as recurrent anal fissures, bleeding, large prolapsing haemorrhoids, etc
• Regular use of fibre supplementation (e.g. Fybogel, Lactulose) over the week prior to the screening visit and no more than 6 standard doses in the past 1 month prior to the screening visit
• Participation in another study with any investigational product within 3 months of screening
• Investigator believes that the participant is physically or mentally unfit to participate in the trial
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 | NL49753.100.14 |