What side effects are associated with this type of intervention?

Common treatments for malnutrition, such as pediatric oral nutritional supplements (ONS), are generally well-tolerated but can have some side effects. These may include gastrointestinal issues like nausea, vomiting, diarrhea, or constipation. Some children might experience bloating or a feeling of fullness. In rare cases, allergic reactions to specific ingredients in the supplements can occur. It is important to monitor the child's response to the supplement and consult with a healthcare provider to manage any adverse effects.

What prior FDA approvals exist?

The FDA has approved various oral nutritional supplements designed to address malnutrition, particularly in pediatric populations. These supplements typically provide a balanced mix of essential nutrients, including vitamins, minerals, proteins, and calories, to support growth and improve nutritional status. Products like Pediasure and Ensure are examples of such supplements that have been widely used to manage malnutrition in children. These supplements are often used in conjunction with dietary counseling to ensure comprehensive nutritional support.

What other types of research exist?

Promising, novel alternatives to Pediatric Oral Nutritional Supplement for malnutrition patients include targeted high-energy supplementation combined with antibiotic treatments such as metronidazole. This approach addresses both nutritional deficiencies and potential microbial overgrowth in the small bowel, leading to improved growth and nutritional status.

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Nutritional Supplement

Oral Nutritional Supplements for Malnutrition in Children

N/A

Waitlist Available

Research Sponsored by Abbott Nutrition

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Child is 36 months - 107 months of age

Be younger than 18 years old

Must not have

Child has been diagnosed with severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis

Child has been diagnosed with clinically significant nutritional deficiency requiring specialty nutritional therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 120 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if giving undernourished children a nutrient-rich drink along with healthy eating advice helps them grow better and become stronger.

Who is the study for?

This trial is for undernourished children aged 3-107 months in the U.S. whose caregivers agree to avoid non-study supplements and follow study procedures. Children with a normal height-for-age score, regular ONS use, acute infections, severe gastrointestinal disorders, hemoglobin disorders, or other significant medical conditions are excluded.

What is being tested?

The trial tests if taking a pediatric oral nutritional supplement (ONS) plus dietary counseling over 120 days improves growth and nutrition in undernourished children compared to just dietary counseling alone. It's randomized: some kids will get the ONS; others won't.

What are the potential side effects?

Potential side effects aren't specified but could include reactions to ingredients in the ONS for those with allergies or intolerances. Regular monitoring should identify any adverse effects from the supplement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child is between 3 and 9 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child has a severe gastrointestinal disorder like celiac disease.

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My child needs special nutrition due to a significant deficiency.

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My child has a diagnosed blood disorder affecting hemoglobin.

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My child has infantile anorexia, a developmental disability like cerebral palsy, or a severe developmental delay.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 120 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 120 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 120 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Weight-for-age z-score (WAZ)

Secondary study objectives

Anthropometric Measurement Calculations

Appetite

Dietary Diversity

+3 more

Other study objectives

Activity Data

Adverse Event Reporting

Caregiver Opinion Questionnaire

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Oral Nutritional Supplement (ONS) GroupExperimental Treatment2 Interventions

Two servings per day in addition to dietary counseling

Group II: Control GroupExperimental Treatment1 Intervention

dietary counseling

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Oral nutritional supplements (ONS) work by providing a concentrated source of essential nutrients, including vitamins, minerals, proteins, and calories, which may be lacking in a malnourished patient's diet. These supplements support growth, improve nutritional status, and address nutrient deficiencies. For malnutrition patients, this is crucial as it promotes weight gain, enhances physical and cognitive development, and stabilizes overall health outcomes.