Irritable Bowel SyndromeIBSQUtritionNCT03720314
Microbiota Profiling in IBS
An observational study of Irritable Bowel Syndrome and Microbial Colonization, run by Wageningen University at 1 site in Netherlands.
Trial summary
This study investigates differences in microbiota profiles and metabolite levels between mild and severe IBS patients, compared to matched healthy controls. Two fecal samples, with one month in between, will be analyzed. Secondary parameters such as dietary intake, quality of life and stool pattern will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Microbial Colonization, Dietary Habits
- What is being tested?
- NA observational study
- How many people
- 121 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Sep 2018to 15 Dec 2018
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 IBS patients, and 30 healthy matched controls. After baseline measurements, the 30 most mild IBS and 30 most severe IBS will be follow-up one month later. n=40 IBS drops out after baseline. Healthy controls will be matched with mild IBS patients, based on age, gender and BMI.
Who may be able to join
- IBS patients that meet the Rome IV criteria, or healthy subjects with no gastro-intesitnal complaints
- In close proximity of Wageningen (max. 50 km)
- Signed informed consent.
- After baseline measurements, IBS severity will be checked using the IBS-SSS. Participants will be included for follow-up one month later, when they have the most mild symptoms (n=30) or most severe (n=30) symptoms.
Who cannot join
- Presence of gastro-intestinal diseases, such as celiac disease, Crohn's disease, or Ulcerative colitis.
- Have a history of intestinal surgery that might interfere with study outcomes. This does not include an appendectomy or cholecystectomy.
- Presence of significant systemic diseases, such as diabetes mellitus, cancer, cardiovascular disease or respiratory disease.
- Female participants: currently pregnant or breast-feeding.
- Use of antibiotic treatment less than 3 months before start of the study and no use of antibiotics during the study.
- You are participant in another study during this study.
Show all 9Show fewer
- Are an employee or student of the Division of Human Nutrition, Food and Biobased Research or Laboratory of Microbiology, of Wageningen University \& Research.
- Unwilling or unable to fulfil study criteria.
- If they are not selected in the most mild or most severe group after T1.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University & Research
Wageningen, Gelderland, 6708WE
About this study
Official title: Microbiota and Metabolite Profiles Linked to Severity in Irritable Bowel Syndrome
This study investigates differences in microbiota profiles and metabolite levels between mild and severe IBS patients, compared to matched healthy controls. Two fecal samples, with one month in between, will be analyzed. Secondary parameters such as dietary intake, quality of life and stool pattern will be assessed.
Read the detailed description
Rationale: Irritable Bowel Syndrome (IBS) is a gastro-intestinal disorder that strongly affects Quality of Life and impairs daily functioning. However, the aetiology and pathophysiology has been poorly understood. Studies suggest that intestinal microbiota in IBS is altered, however a general consensus remains elusive. This may be due to the large individual variation in microbiota and IBS symptoms, and the cross-sectional designs. Moreover, other factors like diet, wellbeing and metabolite profiles are often not taken into account. New evidence is suggesting that IBS severity may be an important factor in microbiota composition.
Objective: To determine faecal microbiota composition and metabolite production (such as acetate, propionate and butyrate), and investigate differences between healthy controls and mild or severe patients IBS. Moreover, to investigate whether (clinical) parameters such as symptom severity fluctuated, and if these fluctuations are associated with an alteration in faecal microbiota composition and metabolite production, one month after baseline, compared to healthy controls.
Study design: This study is a repeated cross-sectional study, with two data collection points (baseline, and after one month).
Study population: For this study, 100 IBS patients and 30 healthy controls will be recruited. After the first data collection point (T1), the 30 most mild and 30 most severe IBS patients will be included for data collection at T2 (after one month). All participants will be aged between 18 and 65 years.
Intervention (if applicable): Not applicable. Main study parameters/endpoints: primary endpoint of this study is microbiota composition and metabolite profiles, and the difference between groups and possible change after one month. These are assessed two faecal samples, which are analysed by 16S rRNA gene-based microbiota profiling. Secondary parameters are dietary intake, Quality of Life, depression and anxiety scores, and stool consistency and frequency, which are assessed by validated questionnaires.
- Being tested
- NA observational study
- Medical subject headings
- Irritable Bowel Syndrome, Communicable Diseases, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NA observational studyOther
observational study
| Study group | Role | What they receive |
|---|---|---|
| IBS | Irritable bowel syndrome patients Receives: Other: NA observational study | |
| control | healthy controls Receives: Other: NA observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microbiota composition
microbiota composition will be measured in fecal samples, using 16S rRNA technique
Measured: baseline, and one month later
Change in Short chain fatty acid levels
Metabolite levels will be measured in fecal samples, using HPLC method
Measured: baseline, and one month later
Secondary outcomes (5)
Dietary intake
Habitual dietary intake and habits will be measured using a Food Frequency Questionnaire.
Measured: baseline
Change in Stool pattern
Using the bristol stool chart, and questions on frequency
Measured: baseline, and one month later
Change in Gastro-intestinal complaints
will be measured using the validated questionnaire IBS-Symptom Severy Score (IBS-SSS). These results range from 0 - 500, and defines subjects in categories. <75 will be considered control/remission, 75-175 is considered mild complaints, 175-300 is considered moderate complaints, >300 is considered severe complaints. Based on results at baseline, the IBS group will be split into most mild and most severe IBS subjects.
Measured: baseline, and one month later
Change in Anxiety and Depression screening scores
Using the questionnaire Hospital Anxiety and Depression Scale (HADS). Seperate scores for anxiety and depression will be calculated, ranging from 0 to 21. Subjects can be considered a "case" of depression and anxiety if scores are above 8.
Measured: baseline, and one month later
Change in Quality of Life scores
The questionnaire IBS-Quality of life (IBS-QoL) will be administered, which calculates a score, ranging from 0 - 100. A higher score indicates a good quality of life.
Measured: baseline, and one month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start6 Sep 2018
- Primary completion15 Dec 2018
- Study completion15 Dec 2018
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports, Ingredia S.A., Nexira, Naturex, Bioiberica, Wecare, Roquette Freres, Darling, Winclove Bio Industries BV
- Responsible party
- Sponsor
- Investigators
- Ben Witteman, Prof MD PhD, Principal investigator, Wageningen University & Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720314
- Sponsor's protocol ID
- NL64950.081.18
- Acronym
- IBSQUtrition
- Status last verified
- Nov 2018
- First submitted
- 6 Aug 2018
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be processed anonymously. Results will be shared in peer reviewed publications
Publications
Wang T, van Dijk L, Rijnaarts I, Hermes GDA, de Roos NM, Witteman BJM, de Wit NJW, Govers C, Smidt H, Zoetendal EG. Methanogen Levels Are Significantly Associated with Fecal Microbiota Composition and Alpha Diversity in Healthy Adults and Irritable Bowel Syndrome Patients. Microbiol Spectr. 2022 Dec 21;10(6):e0165322. doi: 10.1128/spectrum.01653-22. Epub 2022 Nov 2.
PubMed 36321894
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiota and Metabolite Profiles Linked to Severity in Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT03720314
- Acronym / sponsor ID
- IBSQUtrition / NL64950.081.18
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports, Ingredia S.A., Nexira, Naturex, Bioiberica, Wecare, Roquette Freres, Darling, Winclove Bio Industries BV
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 25 Oct 2018 (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.
This study investigates differences in microbiota profiles and metabolite levels between mild and severe IBS patients, compared to matched healthy controls. Two fecal samples, with one month in between, will be analyzed. Secondary parameters such as dietary intake, quality of life and stool pattern will be assessed.
Detailed description
Rationale: Irritable Bowel Syndrome (IBS) is a gastro-intestinal disorder that strongly affects Quality of Life and impairs daily functioning. However, the aetiology and pathophysiology has been poorly understood. Studies suggest that intestinal microbiota in IBS is altered, however a general consensus remains elusive. This may be due to the large individual variation in microbiota and IBS symptoms, and the cross-sectional designs. Moreover, other factors like diet, wellbeing and metabolite profiles are often not taken into account. New evidence is suggesting that IBS severity may be an important factor in microbiota composition.
Objective: To determine faecal microbiota composition and metabolite production (such as acetate, propionate and butyrate), and investigate differences between healthy controls and mild or severe patients IBS. Moreover, to investigate whether (clinical) parameters such as symptom severity fluctuated, and if these fluctuations are associated with an alteration in faecal microbiota composition and metabolite production, one month after baseline, compared to healthy controls.
Study design: This study is a repeated cross-sectional study, with two data collection points (baseline, and after one month).
Study population: For this study, 100 IBS patients and 30 healthy controls will be recruited. After the first data collection point (T1), the 30 most mild and 30 most severe IBS patients will be included for data collection at T2 (after one month). All participants will be aged between 18 and 65 years.
Intervention (if applicable): Not applicable. Main study parameters/endpoints: primary endpoint of this study is microbiota composition and metabolite profiles, and the difference between groups and possible change after one month. These are assessed two faecal samples, which are analysed by 16S rRNA gene-based microbiota profiling. Secondary parameters are dietary intake, Quality of Life, depression and anxiety scores, and stool consistency and frequency, which are assessed by validated questionnaires.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBS | – | Other: NA observational studyIrritable bowel syndrome patients |
| control | – | Other: NA observational studyhealthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 IBS patients, and 30 healthy matched controls. After baseline measurements, the 30 most mild IBS and 30 most severe IBS will be follow-up one month later. n=40 IBS drops out after baseline. Healthy controls will be matched with mild IBS patients, based on age, gender and BMI.
Key inclusion criteria (4 listed)
- IBS patients that meet the Rome IV criteria, or healthy subjects with no gastro-intesitnal complaints
- In close proximity of Wageningen (max. 50 km)
- Signed informed consent.
- After baseline measurements, IBS severity will be checked using the IBS-SSS. Participants will be included for follow-up one month later, when they have the most mild symptoms (n=30) or most severe (n=30) symptoms.
Key exclusion criteria (9 listed)
- Presence of gastro-intestinal diseases, such as celiac disease, Crohn's disease, or Ulcerative colitis.
- Have a history of intestinal surgery that might interfere with study outcomes. This does not include an appendectomy or cholecystectomy.
- Presence of significant systemic diseases, such as diabetes mellitus, cancer, cardiovascular disease or respiratory disease.
- Female participants: currently pregnant or breast-feeding.
- Use of antibiotic treatment less than 3 months before start of the study and no use of antibiotics during the study.
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 |
|---|---|---|
| NA observational studyobservational study | Other | IBS, control |
Primary outcome
Change in microbiota composition
Time frame: baseline, and one month later
microbiota composition will be measured in fecal samples, using 16S rRNA technique
Change in Short chain fatty acid levels
Time frame: baseline, and one month later
Metabolite levels will be measured in fecal samples, using HPLC method
5 secondary outcomes
Dietary intake
Time frame: baseline
Change in Stool pattern
Time frame: baseline, and one month later
Change in Gastro-intestinal complaints
Time frame: baseline, and one month later
Change in Anxiety and Depression screening scores
Time frame: baseline, and one month later
Change in Quality of Life scores
Time frame: baseline, and one month later
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 21 Feb 2019.
- Derived from this study: PubMed 36321894Wang T, van Dijk L, Rijnaarts I, Hermes GDA, de Roos NM, Witteman BJM, de Wit NJW, Govers C, Smidt H, Zoetendal EG. Methanogen Levels Are Significantly Associated with Fecal Microbiota Composition and Alpha Diversity in Healthy Adults and Irritable Bowel Syndrome Patients. Microbiol Spectr. 2022 Dec 21;10(6):e0165322. doi: 10.1128/spectrum.01653-22. Epub 2022 Nov 2.
- Individual participant dataSharing planned: Undecided. Data will be processed anonymously. Results will be shared in peer reviewed publications
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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.
Ben Witteman, Prof MD PhD principal investigator
Wageningen University & Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome and Microbial Colonization, run by Wageningen University 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 4 inclusion and 9 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 21 Feb 2019. 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. 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?
Change in microbiota composition (time frame: baseline, and one month later). The study lists 2 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 NCT03720314, 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 21 Feb 2019.