Short Bowel Syndrome (SBS)AdMIRNCT07530055
Role of the Microbiota in Intestinal Adaptation During Short Bowel Syndrome
A study testing collection of blood and stool/chyme and intestinal biopsy in people with Short Bowel Syndrome (SBS), run by Assistance Publique - Hôpitaux de Paris.
Trial summary
During the first years following intestinal resection, spontaneous physiological adaptations occur in patients with short bowel syndrome (SBS), allowing improvement of the absorptive capacity of the remaining intestine. This adaptation is particularly effective in SBS patients with the colon in continuity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short Bowel Syndrome (SBS)
- What is being tested?
- collection of blood and stool/chyme and intestinal biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Feb 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Diagnosis of short bowel syndrome with a jejunostomy and a plan to restore jejuno-colic continuity within 3 months
- Remaining post-duodenal small intestine (after the ligament of Treitz) < 200 cm
- Remaining colon > 14%
- Remaining small intestine and colon are healthy (no residual inflammatory, post-radiation, or ischemic disease)
- Patient enrolled in a social security system or entitled to coverage
Who cannot join
- Pregnancy
- Patient unable to provide consent:
- Due to a disability preventing consent
- Does not understand French
- Patient deprived of liberty, or under legal protection (guardianship or curatorship)
- Participation in another interventional study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Role of the Microbiota in Intestinal Adaptation During Short Bowel Syndrome: a Longitudinal Follow-up
During the first years following intestinal resection, spontaneous physiological adaptations occur in patients with short bowel syndrome (SBS), allowing improvement of the absorptive capacity of the remaining intestine. This adaptation is particularly effective in SBS patients with the colon in continuity. The specific relationship between this intestinal adaptation and changes in the gut microbiota has not been studied in these patients. We hypothesize that there is a specific relationship between the microbiota and its metabolites and intestinal adaptive capacity, and that certain gut bacteria may promote this spontaneous adaptation.
Read the detailed description
We know that spontaneous adaptation, including weaning from parenteral nutrition, is more likely in patients with short bowel syndrome (SBS) who have the colon in continuity. However, the underlying mechanisms remain unclear. We have shown that the gut microbiota is altered in patients with SBS, with an overabundance of lactic acid bacteria (bacteria responsible for fermentation). It is therefore possible that some of these bacteria may promote spontaneous adaptation and improved absorption in patients with SBS with a colon in continuity, thereby enabling weaning from parenteral nutrition.
In the proposed research, we will study changes in the composition of the gut microbiota in adults with SBS before and at the beginning of the restoration of colonic continuity within the digestive tract (new type 2 SBS patients). To this end, we will compare changes in fecal bacterial populations with the intestine's capacity to adapt and absorb nutrients.
This will make it possible to identify specific factors within the microbiota or in the substances they produce (microbial biomarkers) that could become future targets for improving energy absorption. To address the research question, it is planned to include 15 individuals with SBS, followed in the gastroenterology and nutritional support department at Beaujon Hospital in Clichy
Primary Objective:
To study the relationship between intestinal absorptive capacity in adults with type 2 short bowel syndrome (jejuno-colic anastomosis) and the composition of the fecal microbiota after the restoration of colonic continuity.
- Conditions
- Short Bowel Syndrome (SBS)
- Being tested
- collection of blood and stool/chyme and intestinal biopsy
- Keywords
- Short Bowel Syndrome, Intestinal Adaptation, Gastrointestinal Microbiome
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of blood and stool/chyme and intestinal biopsyOther
The only procedures added by the study are the collection of an additional volume of blood and stool/chyme during samples taken as part of routine care, as well as an intestinal biopsy
| Study group | Role | What they receive |
|---|---|---|
| Patient | Other | Not described Receives: Other: collection of blood and stool/chyme and intestinal biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between intestinal absorptive capacity in adults with type 2 short bowel syndrome after restoration of digestive continuity and changes in the fecal microbiota
Analysis of Intestinal Absorptive Function:
Absorptive capacity is assessed through a stool analysis measuring macronutrients (NIR spectrometry) and energy (bomb calorimetry) excreted in chyme or stool. This assessment is performed on chyme and stool samples collected over a 48-hour period.
Microbiota Analysis:
At inclusion, an intestinal chyme sample (from the jejunostomy pouch) and colonic lumen content are collected.
Stool samples are also collected for microbiota analysis.
Measured: from inclusion until 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel Syndrome (SBS)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530055
- Sponsor's protocol ID
- APHP221024
- Other IDs
- IDRCB: 2025-A01399-40
- Acronym
- AdMIR
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Microbiota in Intestinal Adaptation During Short Bowel Syndrome: a Longitudinal Follow-up
- ClinicalTrials.gov ID
- NCT07530055
- Acronym / sponsor ID
- AdMIR / APHP221024
- Conditions
- Short Bowel Syndrome (SBS)
- Keywords
- Short Bowel Syndrome, Intestinal Adaptation, Gastrointestinal Microbiome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 15 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.
During the first years following intestinal resection, spontaneous physiological adaptations occur in patients with short bowel syndrome (SBS), allowing improvement of the absorptive capacity of the remaining intestine. This adaptation is particularly effective in SBS patients with the colon in continuity. The specific relationship between this intestinal adaptation and changes in the gut microbiota has not been studied in these patients. We hypothesize that there is a specific relationship between the microbiota and its metabolites and intestinal adaptive capacity, and that certain gut bacteria may promote this spontaneous adaptation.
Detailed description
We know that spontaneous adaptation, including weaning from parenteral nutrition, is more likely in patients with short bowel syndrome (SBS) who have the colon in continuity. However, the underlying mechanisms remain unclear. We have shown that the gut microbiota is altered in patients with SBS, with an overabundance of lactic acid bacteria (bacteria responsible for fermentation). It is therefore possible that some of these bacteria may promote spontaneous adaptation and improved absorption in patients with SBS with a colon in continuity, thereby enabling weaning from parenteral nutrition.
In the proposed research, we will study changes in the composition of the gut microbiota in adults with SBS before and at the beginning of the restoration of colonic continuity within the digestive tract (new type 2 SBS patients). To this end, we will compare changes in fecal bacterial populations with the intestine's capacity to adapt and absorb nutrients.
This will make it possible to identify specific factors within the microbiota or in the substances they produce (microbial biomarkers) that could become future targets for improving energy absorption. To address the research question, it is planned to include 15 individuals with SBS, followed in the gastroenterology and nutritional support department at Beaujon Hospital in Clichy
Primary Objective:
To study the relationship between intestinal absorptive capacity in adults with type 2 short bowel syndrome (jejuno-colic anastomosis) and the composition of the fecal microbiota after the restoration of colonic continuity.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | Other | Other: collection of blood and stool/chyme and intestinal biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Diagnosis of short bowel syndrome with a jejunostomy and a plan to restore jejuno-colic continuity within 3 months
- Remaining post-duodenal small intestine (after the ligament of Treitz) < 200 cm
- Remaining colon > 14%
- Remaining small intestine and colon are healthy (no residual inflammatory, post-radiation, or ischemic disease)
Key exclusion criteria (6 listed)
- Pregnancy
- Patient unable to provide consent:
- Due to a disability preventing consent
- Does not understand French
- Patient deprived of liberty, or under legal protection (guardianship or curatorship)
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 |
|---|---|---|
| collection of blood and stool/chyme and intestinal biopsyThe only procedures added by the study are the collection of an additional volume of blood and stool/chyme during samples taken as part of routine care, as well as an intestinal biopsy | Other | Patient |
Primary outcome
Correlation between intestinal absorptive capacity in adults with type 2 short bowel syndrome after restoration of digestive continuity and changes in the fecal microbiota
Time frame: from inclusion until 12 months post surgery
Analysis of Intestinal Absorptive Function: Absorptive capacity is assessed through a stool analysis measuring macronutrients (NIR spectrometry) and energy (bomb calorimetry) excreted in chyme or stool. This assessment is performed on chyme and stool samples collected over a 48-hour period. Microbiota Analysis: At inclusion, an intestinal chyme sample (from the jejunostomy pouch) and colonic lumen content are collected. Stool samples are also collected for microbiota analysis.
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 15 Apr 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing collection of blood and stool/chyme and intestinal biopsy in people with Short Bowel Syndrome (SBS), run by Assistance Publique - Hôpitaux de Paris.
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 6 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: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Francesca Joly, MD (+33 1 40 87 53 32, francisca.joly@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between intestinal absorptive capacity in adults with type 2 short bowel syndrome after restoration of digestive continuity and changes in the fecal microbiota (time frame: from inclusion until 12 months post surgery). 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 15 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.