Protein Sensitive ColitisNCT01813526
Infants With Protein Sensitive Colitis
A study testing Experimental Infant Formula in people with Protein Sensitive Colitis, run by Abbott Nutrition at 2 sites in United States.
Trial summary
Infants with protein sensitive colitis fed a nutritionally complete free amino acid-based medical food will be evaluated for 42 days. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Protein Sensitive Colitis
- What is being tested?
- Experimental Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 1999to Feb 2001
- 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 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Less than or equal to 6 months of age
- 36-42 weeks gestational age at birth
- Singleton or Twin birth
- Diagnosed with protein sensitive colitis
- Negative stool culture at time of study entry
- No previous history of consuming free amino acid-based medical food
Show all 9Show fewer
- Not receiving cisapride or steroids
- No vitamin mineral supplement administration during the study period with the exception of iron or fluoride
- No milk or soy products for the duration of the study
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Children's Hospital
Omaha, Nebraska, 68114
About this study
Official title: Evaluation of an Elemental Formula in Infants With Protein Sensitive Colitis
Infants with protein sensitive colitis fed a nutritionally complete free amino acid-based medical food will be evaluated for 42 days.
- Conditions
- Protein Sensitive Colitis
- 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
Nutritionally complete free amino acid-based medical food.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Infant Formula | Experimental | Experimental formula to be fed ad libitum. Receives: Other: Experimental Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Rated Symptom Score
Calculated from a symptom checklist based on parent report of the previous 7 day history; Change in physician rated symptom score from SD 1 to SD 43.
Measured: Study Day (SD) 1 and 43
Secondary outcomes (5)
Mean Rank Stool Consistency
Parent reported stool records
Measured: Study Day (SD) 2-4 and 40-42
Weight
Weight gain during the feeding period
Measured: Study Day (SD) 1 and 43 Visits
Formula Intake
Parent reported records of formula intake
Measured: Study Day (SD) 2-4 and 40-42
Daily Stool Number
Parent reported stool records
Measured: Study Day (SD) 2-4 and 40-42
Stool Occult Blood
Parent collected sample of infant stool
Measured: Study Day (SD) 2-4 and 40-42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startNov 1999
- Primary completionFeb 2001
- Study completionFeb 2001
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 Protein Sensitive ColitisStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813526
- Sponsor's protocol ID
- AH75
- Status last verified
- Mar 2013
- First submitted
- 14 Mar 2013
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
PubMed 33006765
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Elemental Formula in Infants With Protein Sensitive Colitis
- ClinicalTrials.gov ID
- NCT01813526
- Acronym / sponsor ID
- AH75
- Conditions
- Protein Sensitive Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Nov 1999
- Primary completion
- Feb 2001 (actual)
- Study completion
- Feb 2001 (actual)
- First posted
- 19 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.
Infants with protein sensitive colitis fed a nutritionally complete free amino acid-based medical food will be evaluated for 42 days.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Infant Formula | Experimental | Other: Experimental Infant FormulaExperimental formula to be fed ad libitum. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Less than or equal to 6 months of age
- 36-42 weeks gestational age at birth
- Singleton or Twin birth
- Diagnosed with protein sensitive colitis
- Negative stool culture at time of study entry
Key exclusion criteria (0 listed)
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: EleCareNutritionally complete free amino acid-based medical food. | Other | Experimental Infant Formula |
Primary outcome
Physician Rated Symptom Score
Time frame: Study Day (SD) 1 and 43
Calculated from a symptom checklist based on parent report of the previous 7 day history; Change in physician rated symptom score from SD 1 to SD 43.
5 secondary outcomes
Mean Rank Stool Consistency
Time frame: Study Day (SD) 2-4 and 40-42
Weight
Time frame: Study Day (SD) 1 and 43 Visits
Formula Intake
Time frame: Study Day (SD) 2-4 and 40-42
Daily Stool Number
Time frame: Study Day (SD) 2-4 and 40-42
Stool Occult Blood
Time frame: Study Day (SD) 2-4 and 40-42
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 19 Mar 2013.
- Derived from this study: PubMed 33006765Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
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
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 Protein Sensitive Colitis, 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 9 inclusion and 0 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 19 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 Rated Symptom Score (time frame: Study Day (SD) 1 and 43). 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 NCT01813526, 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 19 Mar 2013; AzTrials last refreshed its copy on 28 Oct 2026.