Short Bowel SyndromeNCT00922805
Fiber Use in Pediatric Short Bowel Syndrome
A study testing guar gum in people with Short Bowel Syndrome, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
Short bowel syndrome (SBS) is a form of disease that results from removal of a significant portion of the intestine leading to poor nutrient absorption. Infants with short bowel syndrome suffer from diarrhea and poor growth. The care of these infants is limited by the lack of effective therapies. Read more about this study
- Who is it for?
- Ages 2 weeks to 1 year
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- guar gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2012
- Phase
- Interventional
- 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 2 weeks to 1 year
- All sexes
- No healthy volunteers
- Child
Pediatric infants (less than 1 y of age) who
- Have Short Bowel Syndrome defined by a history of congenital or surgical loss of intestinal absorptive function resulting in parenteral nutrition dependency of longer than 30 days;
- Are receiving at least 20% of their caloric needs from enteral nutrition and have been on enteral nutrition for at least 1 week following intestinal resection;
- Have increased stool output as manifested by watery stools (3-12/day) and increased ostomy output (20-50 cc/kg/day);
- Have not received antibiotics, probiotics or prebiotics for 2 weeks prior to study entry;
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
Official title: Soluble Fiber Use in Pediatric Short Bowel Syndrome
Short bowel syndrome (SBS) is a form of disease that results from removal of a significant portion of the intestine leading to poor nutrient absorption. Infants with short bowel syndrome suffer from diarrhea and poor growth. The care of these infants is limited by the lack of effective therapies.
Soluble fiber (guar gum) is an indigestible form of sugar that is mostly contained in fruits and vegetables. Soluble fiber can reduce the severity and duration of persistent (constant) diarrhea in children.
The purpose of this research study is to evaluate the many effects of fiber added in the diet of infants with SBS
Read the detailed description
Short bowel syndrome (SBS) is a form of disease that results from removal of a significant portion of the intestine leading to poor nutrient absorption. Infants with short bowel syndrome suffer from diarrhea and poor growth. The care of these infants is limited by the lack of effective therapies. As the intestine tries to grow back some of its length, a process that can take many months, these infants become dependent on intravenous (IV) nutrition in order to survive. Liver disease and sepsis (a blood stream infection) are common complications of IV nutrition and are the two most common causes of death in this population. Therefore, clinicians have tried different ways to improve feeding and shorten the amount of time of IV nutrition, for example continuous feedings through the intestine, use of partly digested formulas and change in diet.
Soluble fiber (guar gum) is an indigestible form of sugar that is mostly contained in fruits and vegetables. Soluble fiber can reduce the severity and duration of persistent (constant) diarrhea in children.
The purpose of this research study is to evaluate the many effects of fiber added in the diet of infants with SBS.
- Conditions
- Short Bowel Syndrome
- Being tested
- guar gum
- Keywords
- Pediatrics, short bowel syndrome, soluble fiber
- 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.
guar gumDietary supplement
Also called Benefiber
guar gum (20 g/l of formula) for one week
| Study group | Role | What they receive |
|---|---|---|
| fiber-enriched formula then fiber-free formula | Active comparator | Subjects first receive a fiber-enriched formula for one week but then will be crossed over and receive a fiber-free formula Receives: Dietary Supplement: guar gum |
| fiber-free formula then fiber-enriched formula | Active comparator | Subjects receive first formula only then will be crossed over and receive a fiber-enriched formula Receives: Dietary Supplement: guar gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soluble fiber supplementation, as a short chain fatty acid precursor, will improve intestinal integrity of infants with SBS
Measured: 4 weeks
Secondary outcomes (1)
Soluble fiber supplementation will improve enteral energy intake of infants with SBS
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- USDA Grand Forks Human Nutrition Research Center, Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- Juliana C Frem, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922805
- Sponsor's protocol ID
- CUMG-108061
- Status last verified
- Jan 2014
- First submitted
- 16 Jun 2009
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soluble Fiber Use in Pediatric Short Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00922805
- Acronym / sponsor ID
- CUMG-108061
- Conditions
- Short Bowel Syndrome
- Keywords
- Pediatrics, short bowel syndrome, soluble fiber
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- USDA Grand Forks Human Nutrition Research Center, Baylor College of Medicine
- Study start
- Jan 2009
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 17 Jun 2009 (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.
Short bowel syndrome (SBS) is a form of disease that results from removal of a significant portion of the intestine leading to poor nutrient absorption. Infants with short bowel syndrome suffer from diarrhea and poor growth. The care of these infants is limited by the lack of effective therapies.
Soluble fiber (guar gum) is an indigestible form of sugar that is mostly contained in fruits and vegetables. Soluble fiber can reduce the severity and duration of persistent (constant) diarrhea in children.
The purpose of this research study is to evaluate the many effects of fiber added in the diet of infants with SBS
Detailed description
Short bowel syndrome (SBS) is a form of disease that results from removal of a significant portion of the intestine leading to poor nutrient absorption. Infants with short bowel syndrome suffer from diarrhea and poor growth. The care of these infants is limited by the lack of effective therapies. As the intestine tries to grow back some of its length, a process that can take many months, these infants become dependent on intravenous (IV) nutrition in order to survive. Liver disease and sepsis (a blood stream infection) are common complications of IV nutrition and are the two most common causes of death in this population. Therefore, clinicians have tried different ways to improve feeding and shorten the amount of time of IV nutrition, for example continuous feedings through the intestine, use of partly digested formulas and change in diet.
Soluble fiber (guar gum) is an indigestible form of sugar that is mostly contained in fruits and vegetables. Soluble fiber can reduce the severity and duration of persistent (constant) diarrhea in children.
The purpose of this research study is to evaluate the many effects of fiber added in the diet of infants with SBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fiber-enriched formula then fiber-free formula | Active comparator | Dietary Supplement: guar gumSubjects first receive a fiber-enriched formula for one week but then will be crossed over and receive a fiber-free formula |
| fiber-free formula then fiber-enriched formula | Active comparator | Dietary Supplement: guar gumSubjects receive first formula only then will be crossed over and receive a fiber-enriched formula |
Who may qualify
- Ages
- 2 weeks to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| guar gumAlso: Benefiberguar gum (20 g/l of formula) for one week | Dietary supplement | fiber-enriched formula then fiber-free formula, fiber-free formula then fiber-enriched formula |
Primary outcome
Soluble fiber supplementation, as a short chain fatty acid precursor, will improve intestinal integrity of infants with SBS
Time frame: 4 weeks
1 secondary outcome
Soluble fiber supplementation will improve enteral energy intake of infants with SBS
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
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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.
Juliana C Frem, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guar gum in people with Short Bowel Syndrome, run by Arkansas Children's Hospital Research Institute 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?
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: withdrawn, as of the sponsor's last update on 15 Jan 2014. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Soluble fiber supplementation, as a short chain fatty acid precursor, will improve intestinal integrity of infants with SBS (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2014.