Inflamatory Bowel DiseaseMicroSigNCT07533890
Fecal Microbiome Signature of Multi-Strain Probiotics Supplementation in Children and Adolescents With Inflammatory Bowel Disease
A study testing Probiotic Formula and Observation in people with Inflamatory Bowel Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
In this study the intestinal microbiome and metabolic profiles of patients with inflammatory bowel disease will be determined upon probiotic intervention. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Inflamatory Bowel Disease
- What is being tested?
- Probiotic Formula and Observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed informed consent
- Diagnosis of inflammatory bowel disease according to actual guidelines (Porto Criteria)
- General good health
- Ability to understand and follow study procedures and understand informed consent
- Age 5 -18 years
- No probiotic therapy 4 weeks before entering into the study.
Who cannot join
- Participation in other clinical studies interfering with study procedures.
- Inability or contraindications to undergo the investigated intervention
- Severe or acute flare of disease (for UC PUCAI score ≥35, for CD wPCDAI >40)
- Treatment escalation within last 4 weeks for uncontrolled disease.
- Antibiotic or probiotic therapy within the last 4 weeks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital, Universitätsspital Bern Kinderklinik
Bern
Christiane Sokollik, PD Dr. med., +41 31 632 21 11, christiane.sokollik@insel.ch
About this study
Official title: Fecal Microbiome Signature of Multi-Strain Probiotics Supplementation in Children and Adolescents With Inflammatory Bowel Disease - an Explanatory 1:1 Randomized Controlled Cross-Over Proof-of-Concept Trial With Blinded Outcome Assessment
In this study the intestinal microbiome and metabolic profiles of patients with inflammatory bowel disease will be determined upon probiotic intervention.
- Conditions
- Inflamatory Bowel Disease
- Being tested
- Probiotic Formula, Observation
- Keywords
- microbiome, inflammatory bowel disease, probiotics
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic FormulaOther
multi-strain probiotics
ObservationOther
Observation
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | 8 week probiotic supplementation, followed by 6 weeks wash-out and 8 weeks oberservation Receives: Other: Probiotic Formula |
| Observation | Other | 8 week observation, followed by 6 weeks washout and 8 week probiotic supplementation Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
abundance of specific bacteria
operational taxonomic units (OTC) presence of total counts at T0, T1,T2,T3
Measured: 22 weeks
Secondary outcomes (4)
microbiome analysis
diversity (Shannon Index) and composition (beta diversity metrics (Bray-Curtis dissimilarity)) at T0,T1,T2,T3
Measured: 22 weeks
clinical response
clinical activity scores: ΔPUCAI for UC, ΔPCDAI for CD at T0,T1,T2,T3
Measured: 22 weeks
laboratory response - local
fecal calprotection at T0,T1,T2,T3
Measured: 22 weeks
laboratory response - systemic
Composite assessment of C-reactive protein, thrombocytes and ESR at T0,T1,T2,T3
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 May 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflamatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trials Unit University of Bern, University of Bern
- Responsible party
- Sponsor
- Investigators
- Christiane Sokollik, Prof, Principal investigator, Division of Paediatric Gastroenterology, Hepatology and Nutrition, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533890
- Sponsor's protocol ID
- 6110
- Acronym
- MicroSig
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiome Signature of Multi-Strain Probiotics Supplementation in Children and Adolescents With Inflammatory Bowel Disease - an Explanatory 1:1 Randomized Controlled Cross-Over Proof-of-Concept Trial With Blinded Outcome Assessment
- ClinicalTrials.gov ID
- NCT07533890
- Acronym / sponsor ID
- MicroSig / 6110
- Conditions
- Inflamatory Bowel Disease
- Keywords
- microbiome, inflammatory bowel disease, probiotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Clinical Trials Unit University of Bern, University of Bern
- Study start
- 1 May 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Apr 2026 (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.
In this study the intestinal microbiome and metabolic profiles of patients with inflammatory bowel disease will be determined upon probiotic intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Other: Probiotic Formula8 week probiotic supplementation, followed by 6 weeks wash-out and 8 weeks oberservation |
| Observation | Other | Other: Observation8 week observation, followed by 6 weeks washout and 8 week probiotic supplementation |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Signed informed consent
- Diagnosis of inflammatory bowel disease according to actual guidelines (Porto Criteria)
- General good health
- Ability to understand and follow study procedures and understand informed consent
- Age 5 -18 years
Key exclusion criteria (5 listed)
- Participation in other clinical studies interfering with study procedures.
- Inability or contraindications to undergo the investigated intervention
- Severe or acute flare of disease (for UC PUCAI score ≥35, for CD wPCDAI >40)
- Treatment escalation within last 4 weeks for uncontrolled disease.
- Antibiotic or probiotic therapy within the last 4 weeks.
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 Formulamulti-strain probiotics | Other | Probiotic |
| ObservationObservation | Other | Observation |
Primary outcome
abundance of specific bacteria
Time frame: 22 weeks
operational taxonomic units (OTC) presence of total counts at T0, T1,T2,T3
4 secondary outcomes
microbiome analysis
Time frame: 22 weeks
clinical response
Time frame: 22 weeks
laboratory response - local
Time frame: 22 weeks
laboratory response - systemic
Time frame: 22 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported, after deidentification
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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.
Christiane Sokollik, Prof principal investigator
Division of Paediatric Gastroenterology, Hepatology and Nutrition, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland
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 Formula and Observation in people with Inflamatory Bowel Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 5 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christiane Sokollik, Prof (+41 31 632 21 11, christiane.sokollik@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
abundance of specific bacteria (time frame: 22 weeks). 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 30 Jun 2026.