Diet/Growth Factor Mechanisms of Gut Adaptation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-10-31

Study Completion Date

2006-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a double-blind randomized controlled study on the clinical and metabolic effects and underlying gut mucosal mechanisms of modified diet, with or without recombinant human growth hormone, in adults with severe short bowel syndrome dependent upon parenteral nutrition. Clinical endpoints include ability to wean patients from parenteral feeding, metabolic endpoints include gut nutrient absorptive function and molecular endpoints include expression of growth factors and nutrient transporters in small bowel and colonic mucosa. The 6-month study is performed, in part, in the General Clinical Research Center for inpatient stays and outpatient visits.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS)

NCT00742157

Short Bowel Syndrome

TERMINATED PHASE4

Evaluation of the Efficacy and Safety of Recombinant Human Growth Hormone (rhGH) in the Treatment of Children With Short Bowel Syndrome

NCT00169637

Short Bowel Syndrome

COMPLETED PHASE3

Growth Hormone for the Treatment of Gastroparesis

NCT06803589

Gastroparesis

RECRUITING EARLY_PHASE1

rHGH and Intestinal Permeability in Intestinal Failure

NCT01380366

Short Bowel Syndrome

COMPLETED PHASE4

Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult Patients

NCT00570011

Growth Hormone Deficiency

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a double-blind randomized controlled study on the clinical and metabolic effects and underlying gut mucosal mechanisms of modified diet, with or without recombinant human growth hormone, in adults with severe short bowel syndrome dependent upon parenteral nutrition. Clinical endpoints include ability to wean patients from parenteral feeding, metabolic endpoints include gut nutrient absorptive function and molecular endpoints include expression of growth factors and nutrient transporters in small bowel and colonic mucosa. The 6-month study is performed, in part, in the General Clinical Research Center for inpatient stays and outpatient visits.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Short Bowel Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

recombinant human growth hormone

Intervention Type DRUG

diet modification

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Parenteral nutrition-dependent adults with short gut syndrome.
* Patients must not have diabetes mellitus or active malignancy within the past 5 years.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No