Short Bowel SyndromePhase 3NCT00169637
Evaluation of the Efficacy and Safety of Recombinant Human Growth Hormone (rhGH) in the Treatment of Children With Short Bowel Syndrome
A Phase 3 study testing rhGH in people with Short Bowel Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This is a randomized controlled, parallel group, open label versus "no treatment" trial which evaluate the efficacy of rhGH on weaning off parenteral nutrition in children with short bowel syndrome.The total follow-up is 14 months; 4 months for each group after randomization; At the end of the first four months: the… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- rhGH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2006to Jun 2008
- Phase
- Phase 3
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 3-18 year with a bone age test under 18-year Children with short bowel syndrome and intestinal insufficiency, the remaining bowel length should be under 80 cm after the first post-surgical period.
- Parenteral nutrition dependency: under parenteral nutrition for at least 3 years with parenteral glycolipidic diet > or = 30% of the total caloric need for age. The parenteral diet should have been stable for at least 3 months.
- Parents consent
Who cannot join
- Over 20% change in caloric daily requirement within the last 6 months before inclusion.
- Surgery on digestive tube within the last 3 months. Administration of drugs targeting digestion (decontamination, macrobiotic, gastric dressing, chelating agents of biliary salts) within the last month.
- History or presence of tumoral process, leukaemia, minor intracranial hypertension, epiphysiolysis, carpal tunnel syndrome.
- Ongoing infection (fever and inflammatory biologic syndrome), progressive inflammatory syndrome.
- Heart failure, renal and respiratory insufficiency. Allergy to solvent. Any condition making impossible the follow-up of the patient during the study. Person participating in another clinical trial or taking another medication under investigation within one month before inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized controlled, parallel group, open label versus "no treatment" trial which evaluate the efficacy of rhGH on weaning off parenteral nutrition in children with short bowel syndrome.The total follow-up is 14 months; 4 months for each group after randomization; At the end of the first four months: the treated group will be followed within 6 months, the untreated group will receive compassionately rhGH for 4 months and followed-up for 6 months after the end of the treatment period.
- Conditions
- Short Bowel Syndrome
- Being tested
- rhGH
- Keywords
- Short bowel syndrome, Growth hormone, Children
- 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.
rhGHDrug
| Study group | Role | What they receive |
|---|---|---|
| GH group (4 months of Growth Hormone) | Experimental | Not described Receives: Drug: rhGH |
| a control (CTR) group (4 months without Growth Hormone, followed by 4 months with GH) | Experimental | 4 months without GH, followed by 4 months with GH Receives: Drug: rhGH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of rhGH compared to "no treatment" on partial or total weaning off of parenteral nutrition in children with short bowel syndrome after 4 months
Measured: 4 months
Secondary outcomes (11)
Evaluate the persistent efficacy (remaining rate of weaning off) 6 months after rhGH discontinuation.
Measured: 6 months
To evaluate the intestinal absorption (input-output within 3 days) at the end of the randomized study (month 4)
Measured: 4 months
To evaluate the intestinal absorption (input-output within 3 days) at the end of study (month 14)
Measured: 14 months
To quantify the variation in body composition (auxology) at the end of the randomized study (month 4)
Measured: 4 months
To quantify the variation in body composition (biphotonic absorptiometry) at the end of the randomized study (month 4)
Measured: 4 months
To quantify the variation in body composition (auxology) at the end of study (month 14)
Measured: 14 months
To quantify the variation in body composition ( biphotonic absorptiometry) at the end of study (month 14)
Measured: 14 months
number of adverse events
Measured: 4 months
number of adverse events glucose intolerance
Measured: 4 months
number of adverse event
To evaluate the tolerance of rhGH at the end of study (month 14).
Measured: 14 months
number of adverse events glucose intolerance
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2006
- Primary completionJun 2008
- Study completionJun 2008
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 Hospices Civils de LyonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain LACHAUX, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169637
- Sponsor's protocol ID
- 2002.301
- Status last verified
- May 2026
- First submitted
- 12 Sep 2005
- Last updated
- 6 May 2026
- Results posted
- No
Publications
Peretti N, Loras-Duclaux I, Kassai B, Restier-Miron L, Guimber D, Gottrand F, Coopman S, Michaud L, Marinier E, Yantren H, Michalski MC, Aubert F, Mercier C, Pelosse M, Lopez M, Chatelain P, Lachaux A. Growth hormone to improve short bowel syndrome intestinal autonomy: a pediatric randomized open-label clinical trial. JPEN J Parenter Enteral Nutr. 2011 Nov;35(6):723-31. doi: 10.1177/0148607111415531. Epub 2011 Oct 5.
PubMed 21975668
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Recombinant Human Growth Hormone (rhGH) in the Treatment of Children With Short Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00169637
- Acronym / sponsor ID
- 2002.301
- Conditions
- Short Bowel Syndrome
- Keywords
- Short bowel syndrome, Growth hormone, Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 15 Sep 2005 (estimated)
- 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 is a randomized controlled, parallel group, open label versus "no treatment" trial which evaluate the efficacy of rhGH on weaning off parenteral nutrition in children with short bowel syndrome.The total follow-up is 14 months; 4 months for each group after randomization; At the end of the first four months: the treated group will be followed within 6 months, the untreated group will receive compassionately rhGH for 4 months and followed-up for 6 months after the end of the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GH group (4 months of Growth Hormone) | Experimental | Drug: rhGH |
| a control (CTR) group (4 months without Growth Hormone, followed by 4 months with GH) | Experimental | Drug: rhGH4 months without GH, followed by 4 months with GH |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 3-18 year with a bone age test under 18-year Children with short bowel syndrome and intestinal insufficiency, the remaining bowel length should be under 80 cm after the first post-surgical period.
- Parenteral nutrition dependency: under parenteral nutrition for at least 3 years with parenteral glycolipidic diet > or = 30% of the total caloric need for age. The parenteral diet should have been stable for at least 3 months.
- Parents consent
Key exclusion criteria (5 listed)
- Over 20% change in caloric daily requirement within the last 6 months before inclusion.
- Surgery on digestive tube within the last 3 months. Administration of drugs targeting digestion (decontamination, macrobiotic, gastric dressing, chelating agents of biliary salts) within the last month.
- History or presence of tumoral process, leukaemia, minor intracranial hypertension, epiphysiolysis, carpal tunnel syndrome.
- Ongoing infection (fever and inflammatory biologic syndrome), progressive inflammatory syndrome.
- Heart failure, renal and respiratory insufficiency. Allergy to solvent. Any condition making impossible the follow-up of the patient during the study. Person participating in another clinical trial or taking another medication under investigation within one month before inclusion.
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 |
|---|---|---|
| rhGH | Drug | GH group (4 months of Growth Hormone), a control (CTR) group (4 months without Growth Hormone, followed by 4 months with GH) |
Primary outcome
Evaluate the efficacy of rhGH compared to "no treatment" on partial or total weaning off of parenteral nutrition in children with short bowel syndrome after 4 months
Time frame: 4 months
11 secondary outcomes
Evaluate the persistent efficacy (remaining rate of weaning off) 6 months after rhGH discontinuation.
Time frame: 6 months
To evaluate the intestinal absorption (input-output within 3 days) at the end of the randomized study (month 4)
Time frame: 4 months
To evaluate the intestinal absorption (input-output within 3 days) at the end of study (month 14)
Time frame: 14 months
To quantify the variation in body composition (auxology) at the end of the randomized study (month 4)
Time frame: 4 months
To quantify the variation in body composition (biphotonic absorptiometry) at the end of the randomized study (month 4)
Time frame: 4 months
To quantify the variation in body composition (auxology) at the end of study (month 14)
Time frame: 14 months
To quantify the variation in body composition ( biphotonic absorptiometry) at the end of study (month 14)
Time frame: 14 months
number of adverse events
Time frame: 4 months
number of adverse events glucose intolerance
Time frame: 4 months
number of adverse event
Time frame: 14 months
number of adverse events glucose intolerance
Time frame: 14 months
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 6 May 2026.
- Results publication: PubMed 21975668Peretti N, Loras-Duclaux I, Kassai B, Restier-Miron L, Guimber D, Gottrand F, Coopman S, Michaud L, Marinier E, Yantren H, Michalski MC, Aubert F, Mercier C, Pelosse M, Lopez M, Chatelain P, Lachaux A. Growth hormone to improve short bowel syndrome intestinal autonomy: a pediatric randomized open-label clinical trial. JPEN J Parenter Enteral Nutr. 2011 Nov;35(6):723-31. doi: 10.1177/0148607111415531. Epub 2011 Oct 5.
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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.
Alain LACHAUX, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rhGH in people with Short Bowel Syndrome, run by Hospices Civils de Lyon 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 3 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: finished, as of the sponsor's last update on 6 May 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Evaluate the efficacy of rhGH compared to "no treatment" on partial or total weaning off of parenteral nutrition in children with short bowel syndrome after 4 months (time frame: 4 months). 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 NCT00169637, 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 6 May 2026.