NCT00169637

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

September 12, 2005

Last Update Submit

May 4, 2026

Conditions

Short Bowel Syndrome

Keywords

Short bowel syndromeGrowth hormoneChildren

Outcome Measures

Primary Outcomes (1)

  • 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

    4 months

Secondary Outcomes (11)

  • Evaluate the persistent efficacy (remaining rate of weaning off) 6 months after rhGH discontinuation.

    6 months

  • To evaluate the intestinal absorption (input-output within 3 days) at the end of the randomized study (month 4)

    4 months

  • To evaluate the intestinal absorption (input-output within 3 days) at the end of study (month 14)

    14 months

  • To quantify the variation in body composition (auxology) at the end of the randomized study (month 4)

    4 months

  • To quantify the variation in body composition (biphotonic absorptiometry) at the end of the randomized study (month 4)

    4 months

  • +6 more secondary outcomes

Study Arms (2)

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

4 months without GH, followed by 4 months with GH

Drug: rhGH

Interventions

rhGHDRUG
GH group (4 months of Growth Hormone)a control (CTR) group (4 months without Growth Hormone, followed by 4 months with GH)

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alain LACHAUX

Lyon, 69437, France

Location

Related Publications (1)

  • 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.

    PMID: 21975668RESULT

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alain LACHAUX, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

June 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

May 6, 2026

Record last verified: 2026-05

Locations

FR(1)