Short Bowel SyndromePhase 4REVENCT03562130
Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics Revestive® in the Management of Short Bowel Syndrome Pediatric Patients
A Phase 4 study testing Teduglutide in people with Short Bowel Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to evaluate if the treatment could maximize intestinal absorption, minimize the inconvenience of diarrhea, and avoid, reduce or eliminate the need for parenteral support (PS) to achieve normal growth, to avoid parenteral nutrition complications and to achieve the best possible quality of… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- Teduglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2018to 13 Jul 2020
- Phase
- Phase 4
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being aged from 2 to 18 years old included ;
- Presenting less than 80 cm of residual small intestine with or without the terminal ileum, ileocecal valve and right colon or having less than 120 cm in case of Short Bowel Syndrome (SBS) caused by Hirschsprung disease;
- Being stable on PN support (inability to significantly reduce PN intake for the last six months before inclusion) ;
- Being dependent on PN for at least 2 years and enterally fed (oral or tube feeding) ;
- Having a normal colonoscopy in the 12 months before screening for children with maintained colon (=SBS type 2 or 3) older than 12 years ;
- Having signed the Informed consent form (or parents or legal representative for minor patients).
Who cannot join
- Having a major gastrointestinal surgical intervention like serial transverse enteroplasty or any other bowel lengthening procedure performed within 6 months of screening ;
- Having a clinically significant untreated intestinal obstruction or active stenosis ;
- Having an unstable absorption due to cystic fibrosis or known DNA abnormalities ;
- Presenting a radiographic or manometric evidence of pseudo-obstruction or severe known dysmotility syndrome, including persistent, severe gastroschisis-related motility disorders ;
- Having an unstable cardiac disease, congenital heart disease or cyanotic disease, with the exception of patients who had undergone ventricular or atrial septal defect repair ;
- Having a history of cancer or clinically significant lymphoproliferative disease; excepted resected cutaneous basal or squamous cell carcinoma, or in situ non-aggressive and surgically resected cancer ;
Show all 17Show fewer
- Having participated in a clinical study using an experimental drug within 1 month or an experimental antibody treatment within 3 months prior to screening, or concurrent participation in any clinical study using an experimental drug that would affect the safety of teduglutide ;
- Having already used native GLP-2 and glucagon-like peptide-1 analog or human growth hormone within 3 months prior to screening ;
- Having already used oral or IV glutamine, octreotide, or dipeptidyl peptidase IV (DPP-IV) inhibitors within 3 months prior to screening ;
- Having an active Crohn's disease which has been treated with biological therapy within the 6 months prior to screening ;
- Having an intestinal polyposis;
- Being, for female patient, both lactating and breast-feeding or having a positive pregnancy test during the screening period;
- Refusing the follow the protocol requirements in terms of birth control ;
- Being unable to follow the study procedures for any reason: psychological, geographical…
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of Summary of Product Characteristics (SPC), or trace residues of tetracycline.
- Active or suspected malignancy.
- Patients with a history of malignancies in the gastrointestinal tract including the hepatobiliary system within the last five years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Monocentric Single-arm Study to Characterize the Long-term Safety, Efficacy, and Pharmacodynamic of GLP-2 Analog (Revestive®) in the Management of Short Bowel Syndrome Pediatric Patients on Home-parenteral Nutrition (HPN)
The purpose of this study is to evaluate if the treatment could maximize intestinal absorption, minimize the inconvenience of diarrhea, and avoid, reduce or eliminate the need for parenteral support (PS) to achieve normal growth, to avoid parenteral nutrition complications and to achieve the best possible quality of life for the patient
Read the detailed description
The short bowel syndrome (SBS) may be defined as a severe malabsorption caused by reduction of intestinal absorptive surface following massive resection of the small intestine. Teduglutide (Revestive®) is an analog of glucagon-like peptide 2 (GLP-2), a naturally occurring hormone that regulates the functional and structural integrity of the cells lining the gastrointestinal tract. The aim of the treatment is to maximize intestinal absorption, minimize the inconvenience of diarrhea, and avoid, reduce or eliminate the need for parenteral support (PS) to achieve the best possible quality of life for the patient. The rationale for the use of Revestive® is based on data obtained, especially in the trial in SBS patients.
Treatment with 0.05 mg/kg/day was safe and well tolerated (no recorded side effects).
Patients remained stable despite substantial reduction in parenteral nutrition (PN) supply as evidenced by stable body weight and height, serum electrolytes, pancreatic enzymes and renal function tests.
Treatment was associated with:
- Reduced PN volume and calories delivered by 25 and 45% respectively with 20% of patients weaned off PN during the study period
- Increased Enteral Nutrition (EN) supply in volume and calories by 40 and 62% respectively
- Increased in plasma citrulline during the treatment period, but decreased after Teduglutide discontinuation The recommended dose of Revestive® in children and adolescents (aged 1 to 17 years) is the same as for adults (0.05 mg/kg body weight once daily).
- Conditions
- Short Bowel Syndrome
- Being tested
- Teduglutide
- Keywords
- Teduglutide, Short Bowel Syndrome, Parenteral nutrition, Intestinal failure
- Medical subject headings
- Short Bowel Syndrome, Hyperphagia, Intestinal Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeduglutideDrug
Daily sub cutaneous injection 0,05 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Revestive | Experimental | Revestive® (teduglutide)is administered in children sub cutaneous injection at 0.05 mg/kg body weight once daily Receives: Drug: Teduglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in parenteral nutrition: Parenteral Nutrition/Resting Energy Expenditure (PN/REE)
Evaluate the efficacy of Revestive® treatment
Measured: At week 24
Secondary outcomes (15)
Ostomy output defined as stool balance testing, urine output and plasma citrulline
Evaluate the impact of Revestive on ostomy flow
Measured: up to week 48
Change in days per week of Parenteral Nutrition (PN)
Quantify the impact of Revestive on the number of perfusion in a week
Measured: up to week 48
Change in number of stool per day
to evaluate the impact of Revestive on diarrhea
Measured: up to week 48
Change in stools consistency (Bristol stool chart)
to evaluate the impact of Revestive on diarrhea
Measured: up to week 48
Ingesta (calorimetric measure)
to evaluate the impact of Revestive on Intestinal absorption
Measured: Every 4 weeks up to week 48
Stool weight/24h
to evaluate the impact of Revestive on Intestinal absorption
Measured: Every 4 weeks up to week 48
Percentage of lipid in stool
to evaluate the impact of Revestive on Intestinal absorption
Measured: Every 4 weeks up to week 48
Percentage of nitrogen in stool
to evaluate the impact of Revestive on Intestinal absorption
Measured: Every 4 weeks up to week 48
Percentage of carbohydrate in stool
to evaluate the impact of Revestive on Intestinal absorption
Measured: Every 4 weeks up to week 48
Percentage of sodium in stool
to evaluate the impact of Revestive on Intestinal absorption
Measured: Every 4 weeks up to week 48
Number of adverse events
to evaluate the long term safety of Revestive
Measured: At week 48
Change in body weight
Measured: At baseline, then at 6 and 12 months
Change in heart rate
Measured: At baseline, then at 6 and 12 months
Change in blood pressure
Measured: At baseline, then at 6 and 12 months
Endogenous GLP-2 rates (antibody ELISA)
to evaluate the response rate of Revestive
Measured: up to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start2 Jul 2018
- Primary completion11 Dec 2019
- Study completion13 Jul 2020
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 Short Bowel SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Imagine Institute, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Olivier GOULET, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562130
- Sponsor's protocol ID
- P171002J
- Other IDs
- 2017-001405-32, 2017
- Acronym
- REVE
- Status last verified
- Sep 2025
- First submitted
- 18 May 2018
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lambe C, Talbotec C, Kapel N, Barbot-Trystram L, Brabant S, Nader EA, Pigneur B, Payen E, Goulet O. Long-term treatment with teduglutide: a 48-week open-label single-center clinical trial in children with short bowel syndrome. Am J Clin Nutr. 2023 Jun;117(6):1152-1163. doi: 10.1016/j.ajcnut.2023.02.019. Epub 2023 May 3.
PubMed 37270289
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocentric Single-arm Study to Characterize the Long-term Safety, Efficacy, and Pharmacodynamic of GLP-2 Analog (Revestive®) in the Management of Short Bowel Syndrome Pediatric Patients on Home-parenteral Nutrition (HPN)
- ClinicalTrials.gov ID
- NCT03562130
- Acronym / sponsor ID
- REVE / P171002J
- Conditions
- Short Bowel Syndrome
- Keywords
- Teduglutide, Short Bowel Syndrome, Parenteral nutrition, Intestinal failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Imagine Institute, URC-CIC Paris Descartes Necker Cochin
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 19 Jun 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.
The purpose of this study is to evaluate if the treatment could maximize intestinal absorption, minimize the inconvenience of diarrhea, and avoid, reduce or eliminate the need for parenteral support (PS) to achieve normal growth, to avoid parenteral nutrition complications and to achieve the best possible quality of life for the patient
Detailed description
The short bowel syndrome (SBS) may be defined as a severe malabsorption caused by reduction of intestinal absorptive surface following massive resection of the small intestine. Teduglutide (Revestive®) is an analog of glucagon-like peptide 2 (GLP-2), a naturally occurring hormone that regulates the functional and structural integrity of the cells lining the gastrointestinal tract. The aim of the treatment is to maximize intestinal absorption, minimize the inconvenience of diarrhea, and avoid, reduce or eliminate the need for parenteral support (PS) to achieve the best possible quality of life for the patient. The rationale for the use of Revestive® is based on data obtained, especially in the trial in SBS patients.
Treatment with 0.05 mg/kg/day was safe and well tolerated (no recorded side effects).
Patients remained stable despite substantial reduction in parenteral nutrition (PN) supply as evidenced by stable body weight and height, serum electrolytes, pancreatic enzymes and renal function tests.
Treatment was associated with:
- Reduced PN volume and calories delivered by 25 and 45% respectively with 20% of patients weaned off PN during the study period
- Increased Enteral Nutrition (EN) supply in volume and calories by 40 and 62% respectively
- Increased in plasma citrulline during the treatment period, but decreased after Teduglutide discontinuation The recommended dose of Revestive® in children and adolescents (aged 1 to 17 years) is the same as for adults (0.05 mg/kg body weight once daily).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Revestive | Experimental | Drug: TeduglutideRevestive® (teduglutide)is administered in children sub cutaneous injection at 0.05 mg/kg body weight once daily |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Being aged from 2 to 18 years old included ;
- Presenting less than 80 cm of residual small intestine with or without the terminal ileum, ileocecal valve and right colon or having less than 120 cm in case of Short Bowel Syndrome (SBS) caused by Hirschsprung disease;
- Being stable on PN support (inability to significantly reduce PN intake for the last six months before inclusion) ;
- Being dependent on PN for at least 2 years and enterally fed (oral or tube feeding) ;
- Having a normal colonoscopy in the 12 months before screening for children with maintained colon (=SBS type 2 or 3) older than 12 years ;
Key exclusion criteria (17 listed)
- Having a major gastrointestinal surgical intervention like serial transverse enteroplasty or any other bowel lengthening procedure performed within 6 months of screening ;
- Having a clinically significant untreated intestinal obstruction or active stenosis ;
- Having an unstable absorption due to cystic fibrosis or known DNA abnormalities ;
- Presenting a radiographic or manometric evidence of pseudo-obstruction or severe known dysmotility syndrome, including persistent, severe gastroschisis-related motility disorders ;
- Having an unstable cardiac disease, congenital heart disease or cyanotic disease, with the exception of patients who had undergone ventricular or atrial septal defect repair ;
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 |
|---|---|---|
| TeduglutideDaily sub cutaneous injection 0,05 mg/kg/day | Drug | Revestive |
Primary outcome
Decrease in parenteral nutrition: Parenteral Nutrition/Resting Energy Expenditure (PN/REE)
Time frame: At week 24
Evaluate the efficacy of Revestive® treatment
15 secondary outcomes
Ostomy output defined as stool balance testing, urine output and plasma citrulline
Time frame: up to week 48
Change in days per week of Parenteral Nutrition (PN)
Time frame: up to week 48
Change in number of stool per day
Time frame: up to week 48
Change in stools consistency (Bristol stool chart)
Time frame: up to week 48
Ingesta (calorimetric measure)
Time frame: Every 4 weeks up to week 48
Stool weight/24h
Time frame: Every 4 weeks up to week 48
Percentage of lipid in stool
Time frame: Every 4 weeks up to week 48
Percentage of nitrogen in stool
Time frame: Every 4 weeks up to week 48
Percentage of carbohydrate in stool
Time frame: Every 4 weeks up to week 48
Percentage of sodium in stool
Time frame: Every 4 weeks up to week 48
Number of adverse events
Time frame: At week 48
Change in body weight
Time frame: At baseline, then at 6 and 12 months
Change in heart rate
Time frame: At baseline, then at 6 and 12 months
Change in blood pressure
Time frame: At baseline, then at 6 and 12 months
Endogenous GLP-2 rates (antibody ELISA)
Time frame: up to week 48
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 11 Sep 2025.
- Results publication: PubMed 37270289Lambe C, Talbotec C, Kapel N, Barbot-Trystram L, Brabant S, Nader EA, Pigneur B, Payen E, Goulet O. Long-term treatment with teduglutide: a 48-week open-label single-center clinical trial in children with short bowel syndrome. Am J Clin Nutr. 2023 Jun;117(6):1152-1163. doi: 10.1016/j.ajcnut.2023.02.019. Epub 2023 May 3.
- Individual participant dataSharing planned: No
Related trials for Short Bowel Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 3
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
Short Bowel Syndrome
Not yet recruitingPhase 2
Efficacy and Safety of TRA16 Administered Orally in Patients With Enteric Hyperoxaluria (EH).
Enteric Hyperoxaluria
RecruitingPhase 3
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
Short Bowel Syndrome
Active, not recruitingObservational study
Registry for Participants With Short Bowel Syndrome
Short Bowel Syndrome
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.
Olivier GOULET, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Teduglutide in people with Short Bowel Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 17 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 11 Sep 2025. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Decrease in parenteral nutrition: Parenteral Nutrition/Resting Energy Expenditure (PN/REE) (time frame: At week 24). 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 NCT03562130, 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 11 Sep 2025.