None listed
Conditions
Interventions
Intervention1: Fruit Chips supplemented with resistant dextrin(FiberSMART® tapioca: -Daily dose of 0.8â??0.85 g/kg body weight of resistant dextrin
-fixed duration of 90 consecutive days.
-The route
Sponsors
AceOne Rs
Eligibility
Inclusion criteria
Inclusion criteria: - Healthy term infants born between 37 and 42 weeks of gestation - Age between 6 and 9 months at the time of enrolment Infants aged 5 point 5 to 8 point 5 months may be screened if enrolment occurs within 2 weeks - Body weight equal to or more than 6 point 5 kg at the time of enrolment - Birth weight appropriate for gestational age between the 20th and 97th percentiles - Currently receiving breast milk and or infant formula with initiation of complementary feeding - Parent or legally acceptable guardian is willing and able to provide written informed consent prior to any study specific procedures - Parent or legally acceptable guardian is willing and able to comply with study procedures including study visits administration of the study product completion of questionnaires and maintenance of study diaries - Infant is generally healthy as determined by medical history and physical examination at screening
Exclusion criteria
Exclusion criteria: - Participation in another clinical trial at the time of enrolment or within the preceding 3 months Preterm birth less than 37 weeks of gestation - Body weight less than 6 point 5 kg at the time of enrolment -Presence of any congenital anomalies or chronic medical conditions that may affect feeding digestion growth or safety assessments - History or presence of gastrointestinal disorders including but not limited to chronic diarrhea persistent vomiting malabsorption syndromes or known food intolerances requiring medical management - Known or suspected immune related disorders or immunodeficiency - Acute infection or illness including fever more than 38 degrees Celsius within 7 days prior to enrolment - Use of antibiotics probiotics prebiotics synbiotics or fiber supplements within 14 days prior to enrolment - Regular consumption of infant formulas supplements or foods containing added prebiotics or probiotics such as inulin fructo oligosaccharides galacto oligosaccharides Lactobacillus or Bifidobacterium - Known or suspected hypersensitivity or allergy to any component of the study product or control product - History of severe allergic reactions including food allergy requiring medical intervention Infants requiring specialized therapeutic diets or medically prescribed nutrition - Any clinically significant abnormality identified during screening physical examination that in the opinion of the Investigator may interfere with study participation or safety evaluation - Parent or legally acceptable guardian unable or unwilling to comply with study procedures or follow up requirements - Infants who in the opinion of the Investigator are unsuitable for participation due to medical safety or compliance considerations that may compromise the integrity of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study will evaluate the safety and tolerability of resistant dextrin in infants during the complementary feeding period. Safety will be assessed by monitoring adverse events and allergic reactions, while gastrointestinal tolerance, crying and sleep patterns, and growth including weight, length, and head circumference will be measured throughout the study. The results will help determine whether resistant dextrin is safe and well tolerated in infantsTimepoint: Visit 1 (Day 0) Visit 2 (Day 21±2 days) Visit 3 (Day 45±2 days) Visit 4 (Day 90±2 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will provide supportive safety data. Occurrence of infections will be monitored through caregiver reports including fever, infection episodes, and medication use. Laboratory safety parameters including blood tests and urinalysis and fecal parameters including fecal occult blood and microbiome analysis will be assessed to detect any clinically significant changes during the studyTimepoint: Visit 1 (Day 0) Visit 2 (Day 21±2 days) Visit 3 (Day 45±2 days) Visit 4 (Day 90±2 days) | — |
Countries
India
Contacts
Public ContactMs Mamatha B Gokavi
SAMAHITHA RESEARCH SOLUTIONS
Outcome results
None listed