ConstipationNCT02234518
Fibers and Gut Health
A study testing High quantity fiber and Low quantity fiber in people with Constipation, run by Société des Produits Nestlé (SPN) at 1 site in Netherlands.
Trial summary
Gastrointestinal discomfort regularly affects >25% of the population worldwide. One of the major contributors to GI discomfort is constipation, which has a prevalence of ~15% and symptoms of which have a significant negative impact on the sufferer's quality of life. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Constipation
- What is being tested?
- High quantity fiber and Low quantity fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18-75; female subjects of child-bearing potential must be willing to use a reliable method of contraception throughout the study period
- BMI: 18.5 - 29.9 kg/m2
- Recruitment based on simplified core ROME III diagnostic criteria for functional constipation (based on specific screening questions):a). average Bristol stool type of 1 - 4 AND frequency of 1 - 3 spontaneous bowel movements (SBMs) per week b). plus at least ONE of: 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 fiber intake (≤18g) determined by the semi-quantitative food intake screener known as the Block Fiber Screener
- Ability to understand the patient information sheet and instructions in Dutch, and able to provide informed consent
Who cannot join
- 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
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- 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
- Regular use of fiber supplementation (e.g. Fybogel, Lactulose) (i.e. no more than 1 standard dose) 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Changes in Gut Transit Time and Gastrointestinal Symptoms Following the Consumption of a Fiber Containing Product in Adults With Constipation
Gastrointestinal discomfort regularly affects >25% of the population worldwide. One of the major contributors to GI discomfort is constipation, which has a prevalence of ~15% and symptoms of which have a significant negative impact on the sufferer's quality of life. One of the hallmarks of chronic constipation is slow progression of contents through the gut (i.e. slow gut / colonic transit time), which may be associated with hard stools that are difficult to expel.
Dietary fiber supplements are widely used as a first-line treatment for constipation although little Level 1 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. Given the promising, yet largely unsubstantiated, benefits of fiber supplementation on symptoms of functional constipation, the objective of this clinical trial is to evaluate tolerance and effectiveness of four week supplementation of a fiber product, in a dose-ranging fashion, on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.
- Conditions
- Constipation
- Being tested
- High quantity fiber, Low quantity fiber, Placebo
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High quantity fiberOther
The intervention type is food product
Low quantity fiberOther
The intervention type is food product
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| High quantity fiber food product | Experimental | Not described Receives: Other: High quantity fiber |
| Low quantity fiber food product | Experimental | Not described Receives: Other: Low quantity fiber |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole gut transit time
To evaluate change in whole gut transit time 2 weeks after consumption of the study product in constipated patients consuming the study product containing fiber in high quantity, compared to those consuming placebo
Measured: After 2 weeks consumption of the study product
Secondary outcomes (4)
Gastrointestinal symptoms
To evaluate change in Gastrointestinal symptoms 2\&4 weeks after consumption of the study product in all groups
Measured: After 2&4 weeks consumption of the study product
Regional colonic transit time
To evaluate change in the regional (right colon, left colon, and rectosigmoid tranist time 2 weeks after consumption of the study product in all groups
Measured: After 2 weeks consumption of the study product
Whole gut transit time
To evaluate change in whole gut transit time 2 weeks after consumption of the study product in constipated patients consuming the study product containing fiber in low quantity, compared to those consuming placebo
Measured: After 2 weeks consumption of the study product
Tolerance
To assess tolerance to the study product 1\&2\&4 weeks after consumption in all groups, using a questionnaire
Measured: After 1&2&4 weeks consumption of the study product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diederick E. Grobbee, Prof, MD, PhD, Principal investigator, Julius Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234518
- Sponsor's protocol ID
- 12.04.NRC
- Status last verified
- Nov 2015
- First submitted
- 2 Sep 2014
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes in Gut Transit Time and Gastrointestinal Symptoms Following the Consumption of a Fiber Containing Product in Adults With Constipation
- ClinicalTrials.gov ID
- NCT02234518
- Acronym / sponsor ID
- 12.04.NRC
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastrointestinal discomfort regularly affects >25% of the population worldwide. One of the major contributors to GI discomfort is constipation, which has a prevalence of ~15% and symptoms of which have a significant negative impact on the sufferer's quality of life. One of the hallmarks of chronic constipation is slow progression of contents through the gut (i.e. slow gut / colonic transit time), which may be associated with hard stools that are difficult to expel.
Dietary fiber supplements are widely used as a first-line treatment for constipation although little Level 1 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. Given the promising, yet largely unsubstantiated, benefits of fiber supplementation on symptoms of functional constipation, the objective of this clinical trial is to evaluate tolerance and effectiveness of four week supplementation of a fiber product, in a dose-ranging fashion, on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High quantity fiber food product | Experimental | Other: High quantity fiber |
| Low quantity fiber food product | Experimental | Other: Low quantity fiber |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women aged 18-75; female subjects of child-bearing potential must be willing to use a reliable method of contraception throughout the study period
- BMI: 18.5 - 29.9 kg/m2
- Recruitment based on simplified core ROME III diagnostic criteria for functional constipation (based on specific screening questions):a). average Bristol stool type of 1 - 4 AND frequency of 1 - 3 spontaneous bowel movements (SBMs) per week b). plus at least ONE of: 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 fiber intake (≤18g) determined by the semi-quantitative food intake screener known as the Block Fiber Screener
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High quantity fiberThe intervention type is food product | Other | High quantity fiber food product |
| Low quantity fiberThe intervention type is food product | Other | Low quantity fiber food product |
| Placebo | Other | Placebo |
Primary outcome
Whole gut transit time
Time frame: After 2 weeks consumption of the study product
To evaluate change in whole gut transit time 2 weeks after consumption of the study product in constipated patients consuming the study product containing fiber in high quantity, compared to those consuming placebo
4 secondary outcomes
Gastrointestinal symptoms
Time frame: After 2&4 weeks consumption of the study product
Regional colonic transit time
Time frame: After 2 weeks consumption of the study product
Whole gut transit time
Time frame: After 2 weeks consumption of the study product
Tolerance
Time frame: After 1&2&4 weeks consumption of the study product
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diederick E. Grobbee, Prof, MD, PhD principal investigator
Julius Clinical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High quantity fiber and Low quantity fiber in people with Constipation, run by Société des Produits Nestlé (SPN) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole gut transit time (time frame: After 2 weeks consumption of the study product). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2015.