Short Bowel SyndromePhase 4rHGHNCT01380366

rHGH and Intestinal Permeability in Intestinal Failure

A Phase 4 study testing Somatropin, Seven Day Food Diary and Fasting in people with Short Bowel Syndrome, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Short Bowel Syndrome
What is being tested?: Somatropin, Seven Day Food Diary and Fasting
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Oct 2006to Feb 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must be between the ages of 18 and 80
Subjects can be male or female
Subjects must have short bowel syndrome with <200cm of functional small bowel or have severe small bowel dysfunction mandating regular (at least two times per week) administration of total parenteral nutrition (TPN) and/or IV fluids.
Subjects must have been dependent on TPN or IV fluids for 1 year, or are expected to be dependent on TPN or IV fluids for at least 1 yr.
Subjects must be patients being seen in the Northwestern intestinal failure clinic
Subjects must be willing to spend one night in the Clinical Research Center
Subjects must be able to read, understand and be able to sign the study specific informed consent

Who cannot join

Subjects must be greater than or equal to 18 years of age, but less than or equal to 80 years of age
Infections requiring antibiotic therapy within one week of starting the study
Subjects must not have evidence of an ongoing malignancy for two years
Subjects must not have history of antibiotic use within one week of initiating the study. Subjects may enroll in the study as long as Visit 1 is at least one week from the last dose of antibiotics.
Subjects that have evidence of acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure
Subjects with known liver disease, positive hepatitis B virus (HBV), or hepatitis C virus (HCV) serology

Show all 11Show fewer

Subjects unwilling to abstain from alcohol 7 days prior to and during the 28 days of Zorbtive® therapy, until completion of Visit 2
Subjects with a known sensitivity to Benzyl Alcohol
Subjects with a known sensitivity to growth hormone
Female subjects that are unable or unwilling to use effective, acceptable birth control methods throughout the study and for up to 6 months after completing treatment with Zorbtive therapy
Female subject with a positive pregnancy test

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern Memorial Hospital
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Influence of Recombinant Human Growth Hormone on Intestinal Permeability and Liver Injury in Intestinal Failure Patients Receiving Parenteral Nutrition (Serono Project)

Patients who are being asked to participate in this study have a short small bowel and will be prescribed to take the medication: Zorbtive® ("Zorbtive/Somatropin/(rHGH)"). Zorbtive® is an FDA approved recombinant human growth hormone (rHGH). The investigators want to see if taking this medication improves small bowel function by helping it to take in food, nutrients, vitamins and minerals. The investigators also believe that if the small bowel is absorbing food and nutrients better, liver function will improve as well. Therefore, liver function will also be monitored during the course of the study by performing blood tests.

Read the detailed description

This is an open-label pilot study in which a convenience sample of 20 subjects will participate for up to 26 months.

At the baseline visit, subjects will sign a consent form after all questions they have are answered. An inpatient appointment will be made at the General Clinical Research Center (GCRC). Subjects will be given instructions to fill out a 7-day food diary the week prior to their inpatient appointment. In this diary, subjects will be asked to record the types and amounts of food they ingest over a 7-day period. This will allow researchers to review subjects' food intake prior to sugar permeability testing. Although each subject serves as his/her own control, this information may be useful upon review of variations in permeability between subjects.

To evaluate the potential hepato-protective effects of improving intestinal barrier function, blood tests evaluating liver injury and function (i.e. ALT, AST, total bilirubin, ALP, GGT) will be obtained. These labs are part of the subject's standard of care follow-up, therefore study staff will abstract these data from the subject's medical record. The sugar permeability testing requires an 8-hour overnight fast, followed by the ingestion of 4 capsules of sucralose (250mg per capsule), 2.0 grams of mannitol, 7.5 grams of lactulose, and 40 grams of sucrose in 150 mL of water. Over the next 5 hours, urine is collected. Intestinal permeability is quantified as the urine ratio of lactulose, mannitol and sucralose. After urine collection is complete, subjects will begin their 28 days of Zorbtive® administration.

All evaluations (subject food diary, bloodwork, and sugar permeability testing) will be repeated 28 days later, within 72 hours of receiving the final dose of Zorbtive®. The bloodwork drawn is part of the subject's standard of care follow-up, therefore study staff will abstract these data from the subject's medical record.

Following completion of study visits at the GCRC, study staff will obtain results of liver injury/ function tests [(ALT), (AST), bilirubin, alkaline phosphatase (ALK or ALP), (GGT)] from the medical record from each routine clinical exam from Month 3 through Month 24, following the 28-day treatment with Zorbtive® therapy. These labs are part of the subject's standard of care follow-up, therefore study staff will abstract these data from the subject's medical record. Subjects will not be asked to return for separate study visits.

Since the intestinal epithelium is completely reconstituted approximately every 7 days, it is anticipated that the potential influences of rHGH on barrier function and related liver injury will be realized by the end of the 28 day study period. The long term durability of any changes observed after 28 days will be observed, but will likely require further study.

Conditions: Short Bowel Syndrome
Being tested: Somatropin, Seven Day Food Diary, Blood Tests (standard of care), Fasting, Sugar Permeability Test
Keywords: Malabsorption
Medical subject headings: Short Bowel Syndrome, Malabsorption Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SomatropinDrug
Also called Recombinant human growth hormone (rHGH), Zorbtive®
Patients are given somatropin (growth hormone) for their short bowel syndrome for 28 days at a dose of 0.1 mg/kg subcutaneously daily to a maximum of 8 mg daily.
Seven Day Food DiaryProcedure or surgery
Subjects are asked to fill out a seven day food diary the week prior to their inpatient appointment, prior to receiving rHGH treatment for their short bowel syndrome. Subjects will be asked to repeat the use of a food diary after completing the administration of the growth hormone.
Blood Tests (standard of care)Procedure or surgery
Blood tests are taken (standard of care) to evaluate the potential hepato-protective effects of improving intestinal barrier function on those receiving human growth hormone for short bowel syndrome. Per clinical protocol to test liver function i.e. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline phosphatase (ALP), Gamma-glutamyl transpeptidase (GGT), Total Bilirubin). A complete blood count (CBC) with platelets (PLTS) and white-count differential (WBC with diff) is performed to check for anemia and infection. These tests will be taken at baseline (before fasting) and repeated again on the 28th day (last dose) of the growth hormone. Blood is also taken at clinical visit over the next two years (approximately every two months).
FastingOther
Eight hour overnight fast prior to being given sucralose, mannitol, lactulose, and sucrose. This is done at baseline (day one) and repeated again after the last dose of growth hormone and prior to sugar permeability urine tests.
Sugar Permeability TestOther
Subject will be given 4 capsules of sucralose (250mg per capsule), 2.0 grams of mannitol, 7.5 grams of lactulose, and 40 grams of sucrose in 150 mL of water. This will be given on the second day of the study after an 8-hour overnight fast and repeated within 72 hours of the last dose of growth hormone.
Urine CollectionOther
Urine will be collected for the following five hours after subject has been given combination of sucralose, mannitol, lactulose, and sucrose to complete the intestinal sugar permeability test looking at urine ratio of lactulose to mannitol (L/M ratio). Tests include urinalysis (UA) and a blood urea nitrogen (BUN)/creatinine (Cr).

Study groups in NCT01380366
Study group	Role	What they receive
Patients consent to rHGH study	Other	Patients consent to be given growth hormone (rHGH) for their short bowel syndrome. Receives: Drug: Somatropin; Procedure: Seven Day Food Diary; Procedure: Blood Tests (standard of care); Other: Fasting; Other: Sugar Permeability Test; Other: Urine Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

To Identify Small Intestinal Permeability Changes in Short Bowel Syndrome Patients After Administration of Recombinant Human Growth Hormone (Zorbtive®).
Permeability changes will be identified in short bowel syndrome patients by evaluating concentration of lactulose, mannitol and sucralose from Visit 1 to Visit 2. A decrease in concentration of sucralose in urine indicates Zorbtive potentially enhancing intestinal barrier function.
Measured: (Visit 1) Baseline to (Visit 2) 28-31 days after baseline

Secondary outcomes (1)

To Evaluate Liver Enzymes in Total Parenteral Nutrition (TPN)-Dependent Short Bowel Syndrome Patients Before and After Administration of Zorbtive®.
Following completion of Visit 2, study staff will obtain results of liver injury/function tests (ALT, Aspartate transaminase (AST), bilirubin, alkaline phosphatase (ALK or ALP), GGT) from the medical record from each routine clinical exam from Month 3 through Month 24. Results that show decreased liver injury (ALT, AST, bilirubin, alkaline phosphate (ALK or ALP), GGT) will show Zorbtive administration enhanced intestinal permeability and enhanced liver function.
Measured: (Visit 1) Baseline, (Visit 2) 28-31 days after baseline, then at regularly scheduled follow-up clinic visits for two years from Month 3 through Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2006Feb 2015

First posted27 Jun 2011 (estimated)
Study startOct 2006
Primary completionFeb 2011
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe 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: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01380366
Sponsor's protocol ID: STU00012123 0208-007
Other IDs: CNV0050754
Acronym: rHGH
Status last verified: Jan 2016
First submitted: 22 Jun 2011
Last updated: 8 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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).
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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
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All Short Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influence of Recombinant Human Growth Hormone on Intestinal Permeability and Liver Injury in Intestinal Failure Patients Receiving Parenteral Nutrition (Serono Project)
ClinicalTrials.gov ID: NCT01380366
Acronym / sponsor ID: rHGH / STU00012123 0208-007
Conditions: Short Bowel Syndrome
Keywords: Malabsorption
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: Northwestern Memorial Hospital, EMD Serono
Study start: Oct 2006
Primary completion: Feb 2011 (actual)
Study completion: Feb 2015 (actual)
First posted: 27 Jun 2011 (estimated)
Results: Posted 31 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is an open-label pilot study in which a convenience sample of 20 subjects will participate for up to 26 months.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patients consent to rHGH study	Other	Drug: Somatropin, Procedure: Seven Day Food Diary, Procedure: Blood Tests (standard of care), Other: Fasting, Other: Sugar Permeability Test, Other: Urine CollectionPatients consent to be given growth hormone (rHGH) for their short bowel syndrome.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Subjects must be between the ages of 18 and 80
Subjects can be male or female
Subjects must have short bowel syndrome with <200cm of functional small bowel or have severe small bowel dysfunction mandating regular (at least two times per week) administration of total parenteral nutrition (TPN) and/or IV fluids.
Subjects must have been dependent on TPN or IV fluids for 1 year, or are expected to be dependent on TPN or IV fluids for at least 1 yr.
Subjects must be patients being seen in the Northwestern intestinal failure clinic

Key exclusion criteria (11 listed)

Subjects must be greater than or equal to 18 years of age, but less than or equal to 80 years of age
Infections requiring antibiotic therapy within one week of starting the study
Subjects must not have evidence of an ongoing malignancy for two years
Subjects must not have history of antibiotic use within one week of initiating the study. Subjects may enroll in the study as long as Visit 1 is at least one week from the last dose of antibiotics.
Subjects that have evidence of acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure

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
SomatropinAlso: Recombinant human growth hormone (rHGH), Zorbtive®Patients are given somatropin (growth hormone) for their short bowel syndrome for 28 days at a dose of 0.1 mg/kg subcutaneously daily to a maximum of 8 mg daily.	Drug	Patients consent to rHGH study
Seven Day Food DiarySubjects are asked to fill out a seven day food diary the week prior to their inpatient appointment, prior to receiving rHGH treatment for their short bowel syndrome. Subjects will be asked to repeat the use of a food diary after completing the administration of the growth hormone.	Procedure or surgery	Patients consent to rHGH study
Blood Tests (standard of care)Blood tests are taken (standard of care) to evaluate the potential hepato-protective effects of improving intestinal barrier function on those receiving human growth hormone for short bowel syndrome. Per clinical protocol to test liver function i.e. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline phosphatase (ALP), Gamma-glutamyl transpeptidase (GGT), Total Bilirubin). A complete blood count (CBC) with platelets (PLTS) and white-count differential (WBC with diff) is performed to check for anemia and infection. These tests will be taken at baseline (before fasting) and repeated again on the 28th day (last dose) of the growth hormone. Blood is also taken at clinical visit over the next two years (approximately every two months).	Procedure or surgery	Patients consent to rHGH study
FastingEight hour overnight fast prior to being given sucralose, mannitol, lactulose, and sucrose. This is done at baseline (day one) and repeated again after the last dose of growth hormone and prior to sugar permeability urine tests.	Other	Patients consent to rHGH study
Sugar Permeability TestSubject will be given 4 capsules of sucralose (250mg per capsule), 2.0 grams of mannitol, 7.5 grams of lactulose, and 40 grams of sucrose in 150 mL of water. This will be given on the second day of the study after an 8-hour overnight fast and repeated within 72 hours of the last dose of growth hormone.	Other	Patients consent to rHGH study
Urine CollectionUrine will be collected for the following five hours after subject has been given combination of sucralose, mannitol, lactulose, and sucrose to complete the intestinal sugar permeability test looking at urine ratio of lactulose to mannitol (L/M ratio). Tests include urinalysis (UA) and a blood urea nitrogen (BUN)/creatinine (Cr).	Other	Patients consent to rHGH study

Primary outcome

To Identify Small Intestinal Permeability Changes in Short Bowel Syndrome Patients After Administration of Recombinant Human Growth Hormone (Zorbtive®).
Time frame: (Visit 1) Baseline to (Visit 2) 28-31 days after baseline
Permeability changes will be identified in short bowel syndrome patients by evaluating concentration of lactulose, mannitol and sucralose from Visit 1 to Visit 2. A decrease in concentration of sucralose in urine indicates Zorbtive potentially enhancing intestinal barrier function.

1 secondary outcome

To Evaluate Liver Enzymes in Total Parenteral Nutrition (TPN)-Dependent Short Bowel Syndrome Patients Before and After Administration of Zorbtive®.
Time frame: (Visit 1) Baseline, (Visit 2) 28-31 days after baseline, then at regularly scheduled follow-up clinic visits for two years from Month 3 through Month 24

Results and safety

Results posted to the registry on 31 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zorptive Subjects	15	15

Primary outcome: To Identify Small Intestinal Permeability Changes in Short Bowel Syndrome Patients After Administration of Recombinant Human Growth Hormone (Zorbtive®).

Time frame: (Visit 1) Baseline to (Visit 2) 28-31 days after baseline. Number. Unit: participants

Measure	Patients Experiencing Decrease in Concentration of Sucralose n = 7
Value	7

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 2 years after enrollment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Consented to be Given rHGH	6 of 15 (40%)	0 of 15 (0%)	Not reported

Limitations and caveats (from the sponsor): Number of participants is low. Time period of evaluation may not have been adequate for evaluating the impact on liver injury. Parameters used to evaluate the impact of gut permeability changes on hepatic inflammation and injury were very limited.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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
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Not yet recruitingPhase 2
Efficacy and Safety of TRA16 Administered Orally in Patients With Enteric Hyperoxaluria (EH).
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Active, not recruitingObservational study
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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.

Jonathan Fryer, MD principal investigator

Northwestern Memorial Hospital, Northwestern University

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 Somatropin, Seven Day Food Diary and Fasting in people with Short Bowel Syndrome, run by Northwestern University at 1 site in United States.

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 7 inclusion and 11 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 8 Feb 2016. 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 United States. 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?

Yes. Results are posted in the registry (first posted 31 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

To Identify Small Intestinal Permeability Changes in Short Bowel Syndrome Patients After Administration of Recombinant Human Growth Hormone (Zorbtive®). (time frame: (Visit 1) Baseline to (Visit 2) 28-31 days after baseline). 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 NCT01380366.

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 8 Feb 2016.