A Phase 4 interventional study of Teduglutide in Short Bowel Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 4, Interventional, and Treatment
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
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:
159 studies on the registry are indexed under Short Bowel Syndrome; 24 are open to participants now.
This study's enrollment of 25 is above the median of 21 across 108 interventional studies indexed under Short Bowel Syndrome.
Browse Short Bowel Syndrome studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Revestive® (teduglutide)is administered in children sub cutaneous injection at 0.05 mg/kg body weight once daily
Drug: Teduglutide
Daily sub cutaneous injection 0,05 mg/kg/day
Decrease in parenteral nutrition: Parenteral Nutrition/Resting Energy Expenditure (PN/REE)
Evaluate the efficacy of Revestive® treatment
Time frame: At week 24
Ostomy output defined as stool balance testing, urine output and plasma citrulline
Evaluate the impact of Revestive on ostomy flow
Time frame: 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
Time frame: up to week 48
Change in number of stool per day
to evaluate the impact of Revestive on diarrhea
Time frame: up to week 48
Change in stools consistency (Bristol stool chart)
to evaluate the impact of Revestive on diarrhea
Time frame: up to week 48
Ingesta (calorimetric measure)
to evaluate the impact of Revestive on Intestinal absorption
Time frame: Every 4 weeks up to week 48
Stool weight/24h
to evaluate the impact of Revestive on Intestinal absorption
Time frame: Every 4 weeks up to week 48
Percentage of lipid in stool
to evaluate the impact of Revestive on Intestinal absorption
Time frame: Every 4 weeks up to week 48
Percentage of nitrogen in stool
to evaluate the impact of Revestive on Intestinal absorption
Time frame: Every 4 weeks up to week 48
Percentage of carbohydrate in stool
to evaluate the impact of Revestive on Intestinal absorption
Time frame: Every 4 weeks up to week 48
Percentage of sodium in stool
to evaluate the impact of Revestive on Intestinal absorption
Time frame: Every 4 weeks up to week 48
Number of adverse events
to evaluate the long term safety of Revestive
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)
to evaluate the response rate of Revestive
Time frame: up to week 48
Plan to share: No
Ran from Jul 2018 to primary completion in Dec 2019, 17 months.
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Teduglutide
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