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Clinical Study For Hospitalized Patients Requiring isocaloric formula for enteral tube feeding

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027831
Enrollment
15
Registered
2020-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: E631- Imbalance of constituents of foodintake

Interventions

Intervention1: MaxvidaTM Advance: 2 Feeds to be administered per day at 0800 Hrs and 1600 Hrs.Dilution of Maxvida Advance is 45g in 170ml water, final volume is 200ml wherein we will be achieving 1kca

Sponsors

Modi Mundi Pharma Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Ready to Sign informed consent form or informed consent form signed by legally acceptable representatives. 2. Aged 18 years and above. 3. Gender: Male & Female. 4. Hospitalized patients requiring isocaloric formula for enteral feeding. 5. Can tolerate enteral tube feeding. 6. Estimated duration of Hospital stay equal to or greater than 2 days.

Exclusion criteria

Exclusion criteria: 1. Receiving tube feeding prior to hospitalization. 2. Patients less than 18 years of age. 3. Patients having allergy to constituents of MaxvidaTM 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

MeasureTime frame
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 (GRV to be checked at 0730 hrs, 0900 hrs, 1530 hrs, 1700 hrs)Timepoint: Day 1 to Day 5

Secondary

MeasureTime frame
1.To Evaluate Change in BMI 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 AEâ??sTimepoint: Day 1 to Day 5

Countries

India

Contacts

Public ContactDr Devesh Kumar

CliniExperts Services Pvt. Ltd.

devesh.kumar@cliniexperts.com

Outcome results

None listed

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