Short Bowel SyndromeNCT03105362
Amino Acid-based Oral Rehydration Solution in Children With Short Bowel Syndrome
A study testing Enterade® oral rehydration solution in people with Short Bowel Syndrome, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This study will assess the tolerability and palatability of an amino acid based oral rehydration solution (enterade®) compared to current oral rehydration solution among children with short bowel syndrome . Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- Enterade® oral rehydration solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2017to 3 Apr 2018
- Phase
- Interventional
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female patients with a diagnosis of short bowel syndrome (as defined by surgical therapy for congenital or acquired gastrointestinal disease) between the ages of 1-17
- Patients who are in intestinal continuity or with diverting ileostomy, jejunostomy
- Patients must be on a stable enteral nutrition regimen with oral rehydration fluids that are taken orally.
- Stable GI medication regimen (e.g., loperamide, cholestyramine, small bowel bacterial overgrowth (SBBO) regimen)
Who cannot join
- Patients receiving IV antibiotics within the previous 72h.
- Patients with a primary diagnosis of a motility disorder (e.g., chronic intestinal pseudo-obstruction) or epithelial cell disorder (e.g., microvillus inclusion disease)
- Malnourished (as defined by Weight/Height Z-score (WHZ) <-2)
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Tolerability of an Amino Acid-based Oral Rehydration Solution in Children With Short Bowel Syndrome
This study will assess the tolerability and palatability of an amino acid based oral rehydration solution (enterade®) compared to current oral rehydration solution among children with short bowel syndrome .
Read the detailed description
Patients with short bowel syndrome (SBS) have a critical reduction of the gut mass/function that is below the minimum needed to absorb nutrients and fluids required for adequate homeostasis. There are limited data regarding the optimal choice for oral rehydration in the setting of SBS that can maximize fluid absorption in the setting of diarrhea with limited intestinal absorptive surface area. The investigators propose a preliminary open label single center study assessing tolerability and palatability of enterade® ( an amino acid (AA) based oral rehydrating solution (ORS)) and compare to baseline. Eligible patients with SBS will participate in a 14-day trial monitoring and measuring tolerability and palatability of an AA-ORS, enterade®, in addition to their regular diet.
- Conditions
- Short Bowel Syndrome
- Being tested
- Enterade® oral rehydration solution
- Keywords
- Oral Rehydration Solutions
- 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.
Enterade® oral rehydration solutionDietary supplement
Commercially available amino acid based oral rehydration solution
| Study group | Role | What they receive |
|---|---|---|
| Amino Acid-ORS arm | Experimental | Patients consumed an amino acid based oral rehydration solution (enterade®) as part of their oral rehydration care plan. Enterade® oral rehydration solution volumes varied from patient to patient depending on baseline clinical need. Receives: Dietary Supplement: Enterade® oral rehydration solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Stool Output Difference (First Week v. Second Week) for Patients With Ostomy
Ostomy output measured as milliliters per day. The mean of outputs where compared between week 1(day 1-7) and week 2 (day 8-14). The difference (of the means) between weeks were reported.
Measured: Total study duration14 days
Average Stool Output Difference (First Week v. Second Week) for Patients in Intestinal Continuity
Output was measured as frequency of stools per day. The mean output was compared between week 1(day 1-7) and week 2 (day 8-14). The difference (of the means) between weeks were reported.
Measured: Total study duration 14 days
Secondary outcomes (1)
Tolerance: Reported Episodes of Abdominal Distension and Emesis
Number of episodes reported of abdominal distension and emesis during study period
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start16 Aug 2017
- Primary completion20 Jan 2018
- Study completion3 Apr 2018
Why it stopped: Issues w/ sponsor and recruitment
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.
- Publications (23)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 Boston Children's HospitalThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label single center pilot study
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Entrinsic Bioscience Inc.
- Responsible party
- Principal investigator, Christopher Duggan, Boston Children's Hospital
- Investigators
- Christopher P Duggan, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105362
- Sponsor's protocol ID
- IRB-P00024854
- Status last verified
- Feb 2020
- First submitted
- 24 Mar 2017
- Last updated
- 24 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Freedman SB, Cho D, Boutis K, Stephens D, Schuh S. Assessing the palatability of oral rehydration solutions in school-aged children: a randomized crossover trial. Arch Pediatr Adolesc Med. 2010 Aug;164(8):696-702. doi: 10.1001/archpediatrics.2010.129.
PubMed 20679159Modi BP, Langer M, Ching YA, Valim C, Waterford SD, Iglesias J, Duro D, Lo C, Jaksic T, Duggan C. Improved survival in a multidisciplinary short bowel syndrome program. J Pediatr Surg. 2008 Jan;43(1):20-4. doi: 10.1016/j.jpedsurg.2007.09.014.
PubMed 18206449Gosselin KB, Duggan C. Enteral nutrition in the management of pediatric intestinal failure. J Pediatr. 2014 Dec;165(6):1085-90. doi: 10.1016/j.jpeds.2014.08.012. Epub 2014 Sep 18. No abstract available.
PubMed 25242686King CK, Glass R, Bresee JS, Duggan C; Centers for Disease Control and Prevention. Managing acute gastroenteritis among children: oral rehydration, maintenance, and nutritional therapy. MMWR Recomm Rep. 2003 Nov 21;52(RR-16):1-16.
PubMed 14627948Faruque AS, Mahalanabis D, Hamadani J, Hoque SS. Hypo-osmolar sucrose oral rehydration solutions in acute diarrhoea: a pilot study. Acta Paediatr. 1996 Oct;85(10):1247-8. doi: 10.1111/j.1651-2227.1996.tb18240.x.
PubMed 8922094World Health Organization. Oral rehydration salts (ORS): A new reduced osmolarity formulation. Geneva: WHO, 2002 Contract No.: September 23, 2002.
Santosham M, Burns BA, Reid R, Letson GW, Duncan B, Powlesland JA, Foster S, Garrett S, Croll L, Nyunt Nyunt W, et al. Glycine-based oral rehydration solution: reassessment of safety and efficacy. J Pediatr. 1986 Nov;109(5):795-801. doi: 10.1016/s0022-3476(86)80696-5.
PubMed 3534198Lima AA, Carvalho GH, Figueiredo AA, Gifoni AR, Soares AM, Silva EA, Guerrant RL. Effects of an alanyl-glutamine-based oral rehydration and nutrition therapy solution on electrolyte and water absorption in a rat model of secretory diarrhea induced by cholera toxin. Nutrition. 2002 Jun;18(6):458-62. doi: 10.1016/s0899-9007(02)00775-x.
PubMed 12044816Nightingale JM. The Sir David Cuthbertson Medal Lecture. Clinical problems of a short bowel and their treatment. Proc Nutr Soc. 1994 Jul;53(2):373-91. doi: 10.1079/pns19940043. No abstract available.
PubMed 7972152Lennard-Jones JE. Oral rehydration solutions in short bowel syndrome. Clin Ther. 1990;12 Suppl A:129-37; discussion 138.
PubMed 2187606Nightingale J, Woodward JM; Small Bowel and Nutrition Committee of the British Society of Gastroenterology. Guidelines for management of patients with a short bowel. Gut. 2006 Aug;55 Suppl 4(Suppl 4):iv1-12. doi: 10.1136/gut.2006.091108. No abstract available.
PubMed 16837533Radlovic V, Lekovic Z, Radlovic N, Lukac M, Ristic D, Simic D, Bijelic M. Significance of the application of oral rehydration solution to maintain water and electrolyte balance in infants with ileostomy. Srp Arh Celok Lek. 2013 May-Jun;141(5-6):325-8. doi: 10.2298/sarh1306325r.
PubMed 23858801Yin L, Gupta R, Vaught L, Grosche A, Okunieff P, Vidyasagar S. An amino acid-based oral rehydration solution (AA-ORS) enhanced intestinal epithelial proliferation in mice exposed to radiation. Sci Rep. 2016 Nov 23;6:37220. doi: 10.1038/srep37220.
PubMed 27876791Ching YA, Modi BP, Jaksic T, Duggan C. High diagnostic yield of gastrointestinal endoscopy in children with intestinal failure. J Pediatr Surg. 2008 May;43(5):906-10. doi: 10.1016/j.jpedsurg.2007.12.037.
PubMed 18485964Duro D, Kalish LA, Johnston P, Jaksic T, McCarthy M, Martin C, Dunn JC, Brandt M, Nobuhara KK, Sylvester KG, Moss RL, Duggan C. Risk factors for intestinal failure in infants with necrotizing enterocolitis: a Glaser Pediatric Research Network study. J Pediatr. 2010 Aug;157(2):203-208.e1. doi: 10.1016/j.jpeds.2010.02.023. Epub 2010 May 6.
PubMed 20447649
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability of an Amino Acid-based Oral Rehydration Solution in Children With Short Bowel Syndrome
- ClinicalTrials.gov ID
- NCT03105362
- Acronym / sponsor ID
- IRB-P00024854
- Conditions
- Short Bowel Syndrome
- Keywords
- Oral Rehydration Solutions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Issues w/ sponsor and recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Entrinsic Bioscience Inc.
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 20 Jan 2018 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Posted 17 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the tolerability and palatability of an amino acid based oral rehydration solution (enterade®) compared to current oral rehydration solution among children with short bowel syndrome .
Detailed description
Patients with short bowel syndrome (SBS) have a critical reduction of the gut mass/function that is below the minimum needed to absorb nutrients and fluids required for adequate homeostasis. There are limited data regarding the optimal choice for oral rehydration in the setting of SBS that can maximize fluid absorption in the setting of diarrhea with limited intestinal absorptive surface area. The investigators propose a preliminary open label single center study assessing tolerability and palatability of enterade® ( an amino acid (AA) based oral rehydrating solution (ORS)) and compare to baseline. Eligible patients with SBS will participate in a 14-day trial monitoring and measuring tolerability and palatability of an AA-ORS, enterade®, in addition to their regular diet.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label single center pilot study
| Arm | Type | Receives |
|---|---|---|
| Amino Acid-ORS arm | Experimental | Dietary Supplement: Enterade® oral rehydration solutionPatients consumed an amino acid based oral rehydration solution (enterade®) as part of their oral rehydration care plan. Enterade® oral rehydration solution volumes varied from patient to patient depending on baseline clinical need. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male and female patients with a diagnosis of short bowel syndrome (as defined by surgical therapy for congenital or acquired gastrointestinal disease) between the ages of 1-17
- Patients who are in intestinal continuity or with diverting ileostomy, jejunostomy
- Patients must be on a stable enteral nutrition regimen with oral rehydration fluids that are taken orally.
- Stable GI medication regimen (e.g., loperamide, cholestyramine, small bowel bacterial overgrowth (SBBO) regimen)
Key exclusion criteria (3 listed)
- Patients receiving IV antibiotics within the previous 72h.
- Patients with a primary diagnosis of a motility disorder (e.g., chronic intestinal pseudo-obstruction) or epithelial cell disorder (e.g., microvillus inclusion disease)
- Malnourished (as defined by Weight/Height Z-score (WHZ) <-2)
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 |
|---|---|---|
| Enterade® oral rehydration solutionCommercially available amino acid based oral rehydration solution | Dietary supplement | Amino Acid-ORS arm |
Primary outcome
Average Stool Output Difference (First Week v. Second Week) for Patients With Ostomy
Time frame: Total study duration14 days
Ostomy output measured as milliliters per day. The mean of outputs where compared between week 1(day 1-7) and week 2 (day 8-14). The difference (of the means) between weeks were reported.
Average Stool Output Difference (First Week v. Second Week) for Patients in Intestinal Continuity
Time frame: Total study duration 14 days
Output was measured as frequency of stools per day. The mean output was compared between week 1(day 1-7) and week 2 (day 8-14). The difference (of the means) between weeks were reported.
1 secondary outcome
Tolerance: Reported Episodes of Abdominal Distension and Emesis
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20679159Freedman SB, Cho D, Boutis K, Stephens D, Schuh S. Assessing the palatability of oral rehydration solutions in school-aged children: a randomized crossover trial. Arch Pediatr Adolesc Med. 2010 Aug;164(8):696-702. doi: 10.1001/archpediatrics.2010.129.
- Background: PubMed 18206449Modi BP, Langer M, Ching YA, Valim C, Waterford SD, Iglesias J, Duro D, Lo C, Jaksic T, Duggan C. Improved survival in a multidisciplinary short bowel syndrome program. J Pediatr Surg. 2008 Jan;43(1):20-4. doi: 10.1016/j.jpedsurg.2007.09.014.
- Background: PubMed 25242686Gosselin KB, Duggan C. Enteral nutrition in the management of pediatric intestinal failure. J Pediatr. 2014 Dec;165(6):1085-90. doi: 10.1016/j.jpeds.2014.08.012. Epub 2014 Sep 18. No abstract available.
- Background: PubMed 14627948King CK, Glass R, Bresee JS, Duggan C; Centers for Disease Control and Prevention. Managing acute gastroenteritis among children: oral rehydration, maintenance, and nutritional therapy. MMWR Recomm Rep. 2003 Nov 21;52(RR-16):1-16.
- Background: PubMed 8922094Faruque AS, Mahalanabis D, Hamadani J, Hoque SS. Hypo-osmolar sucrose oral rehydration solutions in acute diarrhoea: a pilot study. Acta Paediatr. 1996 Oct;85(10):1247-8. doi: 10.1111/j.1651-2227.1996.tb18240.x.
- BackgroundWorld Health Organization. Oral rehydration salts (ORS): A new reduced osmolarity formulation. Geneva: WHO, 2002 Contract No.: September 23, 2002.
- Background: PubMed 3534198Santosham M, Burns BA, Reid R, Letson GW, Duncan B, Powlesland JA, Foster S, Garrett S, Croll L, Nyunt Nyunt W, et al. Glycine-based oral rehydration solution: reassessment of safety and efficacy. J Pediatr. 1986 Nov;109(5):795-801. doi: 10.1016/s0022-3476(86)80696-5.
- Background: PubMed 12044816Lima AA, Carvalho GH, Figueiredo AA, Gifoni AR, Soares AM, Silva EA, Guerrant RL. Effects of an alanyl-glutamine-based oral rehydration and nutrition therapy solution on electrolyte and water absorption in a rat model of secretory diarrhea induced by cholera toxin. Nutrition. 2002 Jun;18(6):458-62. doi: 10.1016/s0899-9007(02)00775-x.
- Background: PubMed 7972152Nightingale JM. The Sir David Cuthbertson Medal Lecture. Clinical problems of a short bowel and their treatment. Proc Nutr Soc. 1994 Jul;53(2):373-91. doi: 10.1079/pns19940043. No abstract available.
- Background: PubMed 2187606Lennard-Jones JE. Oral rehydration solutions in short bowel syndrome. Clin Ther. 1990;12 Suppl A:129-37; discussion 138.
- Background: PubMed 16837533Nightingale J, Woodward JM; Small Bowel and Nutrition Committee of the British Society of Gastroenterology. Guidelines for management of patients with a short bowel. Gut. 2006 Aug;55 Suppl 4(Suppl 4):iv1-12. doi: 10.1136/gut.2006.091108. No abstract available.
- Background: PubMed 23858801Radlovic V, Lekovic Z, Radlovic N, Lukac M, Ristic D, Simic D, Bijelic M. Significance of the application of oral rehydration solution to maintain water and electrolyte balance in infants with ileostomy. Srp Arh Celok Lek. 2013 May-Jun;141(5-6):325-8. doi: 10.2298/sarh1306325r.
- Individual participant dataSharing planned: No
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
Short Bowel Syndrome
Not yet recruitingPhase 2
Efficacy and Safety of TRA16 Administered Orally in Patients With Enteric Hyperoxaluria (EH).
Enteric Hyperoxaluria
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
Short Bowel Syndrome
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.
Christopher P Duggan, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enterade® oral rehydration solution in people with Short Bowel Syndrome, run by Boston Children's Hospital 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 24 Feb 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2019). 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?
Average Stool Output Difference (First Week v. Second Week) for Patients With Ostomy (time frame: Total study duration14 days). The study lists 2 primary outcomes in all. 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 NCT03105362, which also lists 23 linked publications.
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 24 Feb 2020.