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

An Open-label PILOT Clinical Study to evaluate the safety and gastrointestinal tolerance (Product Compliance) of Groviva Advance in Hospitalized children requiring isocaloric formula for enteral tube feeding

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/08/044929

Enrollment

Registered

2022-08-25

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

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

Interventions

Intervention1: Groviva Advance: GrovivaTM is a Nutrition Supplement to support growth and development in Children. 2 Feeds to be administered per day at 0800 Hrs and 1600 Hrs Dilution of Groviva Adva

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1.To study Continuous GI tolerance (Product Compliance): a.Diarrhea free day b.Stomach irritation c.Regurgitation d.Abdominal bloating e.Vomiting f.GRV 500 mlTimepoint: 1.To study Continuous GI tolerance (Product Compliance): a.Diarrhea free day b.Stomach irritation c.Regurgitation d.Abdominal bloating e.Vomiting f.GRV 500 ml	—

Secondary

Measure	Time frame
1.To Evaluate Change in weight (kg) during pre and post intervention of the study product 2.To Evaluate Change in serum albumin during pre and post intervention of the study product 3.Adverse event and serious adverse event monitoring based on clinical and laboratory AEÃ¢â?¬â?¢sTimepoint: Feeds of the study product will be administered per day at 0800 hrs. and 1600 hrs. along with hospital kitchen feed at 1000 hrs., 1200 hrs., and 2000 hrs.	—

Measure

Time frame

1.To Evaluate Change in weight (kg) during pre and post intervention of the study product 2.To Evaluate Change in serum albumin during pre and post intervention of the study product 3.Adverse event and serious adverse event monitoring based on clinical and laboratory AEÃ¢â?¬â?¢sTimepoint: Feeds of the study product will be administered per day at 0800 hrs. and 1600 hrs. along with hospital kitchen feed at 1000 hrs., 1200 hrs., and 2000 hrs.

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Countries

India

Contacts

Public ContactDr Parag Dekate

Krishna Institute Of Medical Sciences Ltd.

drparag.dekate@kimscuddles.com7506866005

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026