A study to check the effect and safety of Groviva Advance on the stomach and intestines in hospitalized children requiring diets having similar calories for tube feeding

Phase 4

• Conditions: Health Condition 1: K929- Disease of digestive system, unspecified

• Registration Number: CTRI/2022/08/044929
• Lead Sponsor: Dr Chetan Mehndiratta Modi Mundi Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Ready to Sign informed consent form or informed consent form signed by

legally acceptable representatives.

2.Aged 2-18 years

3.Gender: Male & Female.

4.Hospitalized patients requiring isocaloric formula for enteral feeding.

5.Can tolerate enteral tube feeding.

6.Estimated duration of Hospital stays equal to or greater than 2 days.

Exclusion Criteria

1.Receiving tube feeding prior to hospitalization.

2.Patients more than 18 years of age.

3.Patients having allergy to constituents of Groviva Advance.

4.Any evidence of organ dysfunction or any clinically significant deviation from the normal, in

physical or clinical determinations.

5.History of renal, hepatic, cardiovascular, respiratory, skin, hematological, endocrine, neurological,

or gastrointestinal diseases.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To study Continuous GI tolerance (Product Compliance): <br/ ><br>a.Diarrhea free day <br/ ><br>b.Stomach irritation <br/ ><br>c.Regurgitation <br/ ><br>d.Abdominal bloating <br/ ><br>e.Vomiting <br/ ><br>f.GRV 500 mlTimepoint: 1.To study Continuous GI tolerance (Product Compliance): <br/ ><br>a.Diarrhea free day <br/ ><br>b.Stomach irritation <br/ ><br>c.Regurgitation <br/ ><br>d.Abdominal bloating <br/ ><br>e.Vomiting <br/ ><br>f.GRV 500 ml

Secondary Outcome Measures

Name	Time	Method
1.To Evaluate Change in weight (kg) during pre and post intervention of the <br/ ><br>study product <br/ ><br>2.To Evaluate Change in serum albumin during pre and post intervention of <br/ ><br>the study product <br/ ><br>3.Adverse event and serious adverse event monitoring based on clinical and <br/ ><br>laboratory AE�sTimepoint: Feeds of the study product will be administered per day at 0800 hrs. and 1600 hrs. along with <br/ ><br>hospital kitchen feed at 1000 hrs., 1200 hrs., and 2000 hrs.