Growth and Tolerance Infant StudyNCT01812629
Nutritional Management of Children With Chronic Diarrhea
A study testing Experimental Infant Formula in people with Growth and Tolerance Infant Study, run by Abbott Nutrition at 2 sites in United States.
Trial summary
The study objective is to assess the growth, tolerance and efficacy of a complete amino acid-based medical food in children with chronic diarrhea. Read more about this study
- Who is it for?
- Ages Up to 9 months
- Conditions the study is for
- Growth and Tolerance Infant Study
- What is being tested?
- Experimental Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 1997to Jun 1999
- 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 Up to 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Less than or equal to 9 months of age at enrollment
- Candidates for an elemental formula
- Chronic diarrhea and diagnosis of one of the following conditions: short-bowel syndrome, eosinophilic gastroenteritis, food allergy, inflammatory bowel disease, pancreatic disease, protein maldigestion, HIV-advanced disease or other underlying GI disease with chronic diarrhea controlled by a semi-elemental or elemental formula
- Parents agree to feed infant with experimental formula for least 50% of total calories during study period
Who cannot join
- Any non-approved concomitant study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Clinical Management of Children With Chronic Diarrhea
The study objective is to assess the growth, tolerance and efficacy of a complete amino acid-based medical food in children with chronic diarrhea.
- Conditions
- Growth and Tolerance Infant Study
- Being tested
- Experimental Infant Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Infant FormulaOther
Also called EleCare
Infant formula to be fed ad libitum
| Study group | Role | What they receive |
|---|---|---|
| Experimental Infant Formula | Experimental | Complete peptide amino acid-based infant formula Receives: Other: Experimental Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician determined target outcome
Outcome dependent on individual subject assessment and may include decreased stool number, decreased vomiting, decreased gas, weight gain, increased caloric intake, increased protein intake, increased serum albumin concentration, increased hemoglobin concentration, better acceptance of supplemental formula.
Measured: Study Day (SD)1-84
Secondary outcomes (5)
Dietary Assessment
Parent completed record of infant dietary intake.
Measured: Study day (SD) 2-4, 5-7, 25-27 and 81-83
Gastro-Intestinal Tolerance
Parent reported record of incidence of regurgitation.
Measured: Study Day (SD) 2-4, 5-7, 25-27, 81-83
Stool characteristics
Parent completed diary of stool consistency, frequency/volume.
Measured: Study Day (SD) 2-4, 5-7, 25-27 and 81-83
Blood Chemistry
Hemoglobin, hematocrit, serum albumin, total protein, urea nitrogen, alkaline phosphatase
Measured: Study Day (SD) 1 and 84
Anthropometrics
Weight and length
Measured: Study Day (SD) 1, 28 and 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startJul 1997
- Primary completionJun 1999
- Study completionJun 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth and Tolerance Infant StudyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marlene Borschel, PhD, RD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812629
- Sponsor's protocol ID
- AH72
- Status last verified
- Mar 2013
- First submitted
- 14 Mar 2013
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Borschel MW, Antonson DL, Murray ND, Oliva-Hemker M, Mattis LE, Kerzner B, Tolia V, Baggs G. Two single group, prospective, baseline-controlled feeding studies in infants and children with chronic diarrhea fed a hypoallergenic free amino acid-based formula. BMC Pediatr. 2014 May 29;14:136. doi: 10.1186/1471-2431-14-136.
PubMed 24885833
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Management of Children With Chronic Diarrhea
- ClinicalTrials.gov ID
- NCT01812629
- Acronym / sponsor ID
- AH72
- Conditions
- Growth and Tolerance Infant Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Jul 1997
- Primary completion
- Jun 1999 (actual)
- Study completion
- Jun 1999 (actual)
- First posted
- 18 Mar 2013 (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.
The study objective is to assess the growth, tolerance and efficacy of a complete amino acid-based medical food in children with chronic diarrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Infant Formula | Experimental | Other: Experimental Infant FormulaComplete peptide amino acid-based infant formula |
Who may qualify
- Ages
- Up to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Less than or equal to 9 months of age at enrollment
- Candidates for an elemental formula
- Chronic diarrhea and diagnosis of one of the following conditions: short-bowel syndrome, eosinophilic gastroenteritis, food allergy, inflammatory bowel disease, pancreatic disease, protein maldigestion, HIV-advanced disease or other underlying GI disease with chronic diarrhea controlled by a semi-elemental or elemental formula
- Parents agree to feed infant with experimental formula for least 50% of total calories during study period
Key exclusion criteria (1 listed)
- Any non-approved concomitant study
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 |
|---|---|---|
| Experimental Infant FormulaAlso: EleCareInfant formula to be fed ad libitum | Other | Experimental Infant Formula |
Primary outcome
Physician determined target outcome
Time frame: Study Day (SD)1-84
Outcome dependent on individual subject assessment and may include decreased stool number, decreased vomiting, decreased gas, weight gain, increased caloric intake, increased protein intake, increased serum albumin concentration, increased hemoglobin concentration, better acceptance of supplemental formula.
5 secondary outcomes
Dietary Assessment
Time frame: Study day (SD) 2-4, 5-7, 25-27 and 81-83
Gastro-Intestinal Tolerance
Time frame: Study Day (SD) 2-4, 5-7, 25-27, 81-83
Stool characteristics
Time frame: Study Day (SD) 2-4, 5-7, 25-27 and 81-83
Blood Chemistry
Time frame: Study Day (SD) 1 and 84
Anthropometrics
Time frame: Study Day (SD) 1, 28 and 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2013.
- Derived from this study: PubMed 24885833Borschel MW, Antonson DL, Murray ND, Oliva-Hemker M, Mattis LE, Kerzner B, Tolia V, Baggs G. Two single group, prospective, baseline-controlled feeding studies in infants and children with chronic diarrhea fed a hypoallergenic free amino acid-based formula. BMC Pediatr. 2014 May 29;14:136. doi: 10.1186/1471-2431-14-136.
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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.
Marlene Borschel, PhD, RD study chair
Abbott Nutrition
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Infant Formula in people with Growth and Tolerance Infant Study, run by Abbott Nutrition at 2 sites 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 1 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 18 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physician determined target outcome (time frame: Study Day (SD)1-84). 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 NCT01812629, which also lists 1 linked publication.
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 18 Mar 2013.