Nutritional Management of Infants With Chronic Diarrhea

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01820494

Enrollment

Registered

2013-03-28

Start date

2000-10-31

Completion date

2002-11-30

Last updated

2013-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth and Tolerance Infant Study

Keywords

growth, infants

Brief summary

The study objective is to assess the growth of infants fed an experimental formula for the nutritional management of chronic diarrhea.

Interventions

OTHERExperimental Infant Formula

Infant formula to be fed ad libitum

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 12 Months

Healthy volunteers

Inclusion criteria

* Less than or equal to 12 months of age at enrollment * Candidates for elemental feeding * 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 GI disease requiring an elemental diet or have underlying GI disease without chronic diarrhea if his/her chronic diarrhea is controlled or is in remission by a semi-elemental or elemental formula for no more than 13 weeks * Parents agree to feed infant with experimental formula for least 50% of total calories during study period

Exclusion criteria

* Any non-approved concomitant study

Design outcomes

Primary

Measure	Time frame	Description
Weight	Study Day (SD) 1, 28 and 84	Change in weight from baseline.

Secondary

Measure	Time frame	Description
Stool Characteristics	Study Day (SD) 2-4, 5-7, 25-27 and 81-83	Parent completed diary of stool consistency, frequency/volume.

Other

Measure	Time frame	Description
Dietary Assessment	Study day (SD) 2-4, 5-7, 25-27 and 81-83	Parent completed record of infant dietary intake.
Blood Chemistry	Study Day (SD) 1 and 84	Hemoglobin, hematocrit, serum albumin, total protein, urea nitrogen, alkaline phosphatase
Physician Assessment of Abdominal Complaints	Study Day (SD) 1, 28 and 84	Individualized per subject, may include decreased vomiting, stool number or volume or increased weight gain.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026