Irritable Bowel SyndromeNUTRICNCT04798417
Nutrition to Relieve IBS Constipation
A study testing Probiotic supplement, Prebiotic supplement and Maltodextrin in people with Irritable Bowel Syndrome and Constipation, run by Wageningen University and Research at 1 site in Netherlands.
Trial summary
Rationale: 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome, Constipation
- What is being tested?
- Probiotic supplement, Prebiotic supplement and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Mar 2021to 15 Jul 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IBS patients that meet the Rome IV criteria + additional criteria specific for the constipation-predominant subtype, based on the most frequent self-reported stool types using the Bristol stool chart (BSC). These criteria will be assessed via the inclusion questionnaire and will be evaluated by the medical supervisor.
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG
About this study
Rationale: 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.
Objective: The primary objective is to determine the effects of a 4-week intervention with either a prebiotic supplement or a probiotic supplement on stool pattern (including stool frequency, consistency, and volume) in IBS-C patients. The secondary objective is to determine the effects if this intervention on GI complaints and quality of life in IBS-C patients.
Read more
Study design: A double-blind, randomized, placebo-controlled trial will be conducted with three parallel intervention arms Study population: 180 adult (18-70 yrs) IBS patients with a constipation-predominant subtype Intervention: A 4 week run-in period will be followed by a 4-week intervention period with three parallel arms: 1) prebiotic supplement, 2) probiotic supplement, and 3) Placebo supplement, during which the study participants consume the respective supplement twice per day.
Main study parameters/endpoints: The primary study parameter is stool pattern: stool frequency, stool consistency; and stool volume. The secondary study parameters are gastrointestinal complaints, Quality of Life, and HADS.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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 consecutive days. There are limited risks for the study participants.
- Conditions
- Irritable Bowel Syndrome, Constipation
- Being tested
- Probiotic supplement, Prebiotic supplement, Maltodextrin
- Keywords
- Prebiotic, Probiotic
- Medical subject headings
- Irritable Bowel Syndrome, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic supplementDietary supplement
Use of a probiotic sachet
Prebiotic supplementDietary supplement
Prebiotic sachets
MaltodextrinDietary supplement
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Not described Receives: Dietary Supplement: Probiotic supplement |
| Prebiotic | Experimental | Not described Receives: Dietary Supplement: Prebiotic supplement |
| Maltodextrin | Placebo comparator | Not described Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool frequency
Number of stools per day will be questioned
Measured: Change after the intervention, measured at week 1, week 4 and week 8
Stool consistency
Will be assessed using the Bristol stool Chart
Measured: Change after the intervention, measured at week 1, week 4 and week 8
stool volume
Participants will weigh every stool that they have during 5 days
Measured: Change after the intervention, measured at week 4 and week 8
Secondary outcomes (6)
Constipation severity
Will be measured using the validated questionnaire PAC-SYM
Measured: during week 1, week 4 and week 8 of the study
Irritable Bowel Syndrome severity
Will be measured using the validated questionnaire IBS-SSS
Measured: during week 1, week 4 and week 8 of the study
Constipation related quality of life
will be measured using the validated questionnaire PAC-QOL
Measured: during week 1, week 4 and week 8 of the study
Dietary intake
will be measured using a validated food frequency questionnaire
Measured: during week 1, week 4 and week 8 of the study
Mental wellbeing
Will be measured using the validated HADS questionnaire
Measured: during week 1, week 4 and week 8 of the study
gastro-intestinal complaints
will be measured on a visual analog scale
Measured: daily for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start8 Mar 2021
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Collaborators
- Ministery of Economic affairs, Nexira, Wecare, Roquette Freres, Ingredion Incorporated, Ingredia S.A., Naturex, Winclove Probiotics B.V., Bioiberica, Darling Ingredients
- Responsible party
- Principal investigator, Diederik Esser, Wageningen University and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798417
- Sponsor's protocol ID
- NL76449.041.21
- Acronym
- NUTRIC
- Status last verified
- Jul 2021
- First submitted
- 4 Mar 2021
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
JanssenDuijghuijsen L, van den Belt M, Rijnaarts I, Vos P, Guillemet D, Witteman B, de Wit N. Acacia fiber or probiotic supplements to relieve gastrointestinal complaints in patients with constipation-predominant IBS: a 4-week randomized double-blinded placebo-controlled intervention trial. Eur J Nutr. 2024 Aug;63(5):1983-1994. doi: 10.1007/s00394-024-03398-8. Epub 2024 Apr 23.
PubMed 38653808
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition to Relieve IBS Constipation
- ClinicalTrials.gov ID
- NCT04798417
- Acronym / sponsor ID
- NUTRIC / NL76449.041.21
- Conditions
- Irritable Bowel Syndrome, Constipation
- Keywords
- Prebiotic, Probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Collaborators
- Ministery of Economic affairs, Nexira, Wecare, Roquette Freres, Ingredion Incorporated, Ingredia S.A., Naturex, Winclove Probiotics B.V., Bioiberica, Darling Ingredients
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 15 Mar 2021 (actual)
- 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.
Rationale: 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.
Objective: The primary objective is to determine the effects of a 4-week intervention with either a prebiotic supplement or a probiotic supplement on stool pattern (including stool frequency, consistency, and volume) in IBS-C patients. The secondary objective is to determine the effects if this 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 Study population: 180 adult (18-70 yrs) IBS patients with a constipation-predominant subtype Intervention: A 4 week run-in period will be followed by a 4-week intervention period with three parallel arms: 1) prebiotic supplement, 2) probiotic supplement, and 3) Placebo supplement, during which the study participants consume the respective supplement twice per day.
Main study parameters/endpoints: The primary study parameter is stool pattern: stool frequency, stool consistency; and stool volume. The secondary study parameters are gastrointestinal complaints, Quality of Life, and HADS.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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 consecutive days. There are limited risks for the study participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic supplement |
| Prebiotic | Experimental | Dietary Supplement: Prebiotic supplement |
| Maltodextrin | Placebo comparator | Dietary Supplement: Maltodextrin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- IBS patients that meet the Rome IV criteria + additional criteria specific for the constipation-predominant subtype, based on the most frequent self-reported stool types using the Bristol stool chart (BSC). These criteria will be assessed via the inclusion questionnaire and will be evaluated by the medical supervisor.
- 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
Key exclusion criteria (11 listed)
- 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).
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 |
|---|---|---|
| Probiotic supplementUse of a probiotic sachet | Dietary supplement | Probiotic |
| Prebiotic supplementPrebiotic sachets | Dietary supplement | Prebiotic |
| MaltodextrinPlacebo comparator | Dietary supplement | Maltodextrin |
Primary outcome
Stool frequency
Time frame: Change after the intervention, measured at week 1, week 4 and week 8
Number of stools per day will be questioned
Stool consistency
Time frame: Change after the intervention, measured at week 1, week 4 and week 8
Will be assessed using the Bristol stool Chart
stool volume
Time frame: Change after the intervention, measured at week 4 and week 8
Participants will weigh every stool that they have during 5 days
6 secondary outcomes
Constipation severity
Time frame: during week 1, week 4 and week 8 of the study
Irritable Bowel Syndrome severity
Time frame: during week 1, week 4 and week 8 of the study
Constipation related quality of life
Time frame: during week 1, week 4 and week 8 of the study
Dietary intake
Time frame: during week 1, week 4 and week 8 of the study
Mental wellbeing
Time frame: during week 1, week 4 and week 8 of the study
gastro-intestinal complaints
Time frame: daily for 8 weeks
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 30 Jul 2021.
- Derived from this study: PubMed 38653808JanssenDuijghuijsen L, van den Belt M, Rijnaarts I, Vos P, Guillemet D, Witteman B, de Wit N. Acacia fiber or probiotic supplements to relieve gastrointestinal complaints in patients with constipation-predominant IBS: a 4-week randomized double-blinded placebo-controlled intervention trial. Eur J Nutr. 2024 Aug;63(5):1983-1994. doi: 10.1007/s00394-024-03398-8. Epub 2024 Apr 23.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic supplement, Prebiotic supplement and Maltodextrin in people with Irritable Bowel Syndrome and Constipation, run by Wageningen University and Research 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 5 inclusion and 11 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 30 Jul 2021. 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?
Stool frequency (time frame: Change after the intervention, measured at week 1, week 4 and week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04798417, which also lists 1 linked publication.
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 30 Jul 2021.