Effect of a fibre-enriched versus standard pediatric tube feed on the intestinal flora, gastrointestinal function and nutritional status of 7-12 year old children.

Completed

• Conditions: <br />2. children aged 7-12 years; 1. Tube fed; <br />3. cerebral palsy.

• Registration Number: NL-OMON22400
• Lead Sponsor: umico Research B.V.

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 27

Inclusion Criteria

Children:

1. male and female subjects, aged 7-12 years, who are expected to need tube feeding for at least 8 months;

Exclusion Criteria

Children:

1. with Cow’s Milk Allergy, inflammatory bowel disease or bowel resection;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut microflora.

Secondary Outcome Measures

Name	Time	Method
1. Bowel function: stool frequency, consistency and reduction of laxative use;<br /><br>2. Gastro-intestinal intolerance (eg: bloating, abdominal pain, nausea); <br /><br>3. Nutritional status, assessed by measuring anthropometrics, micronutrient status and body composition.