Prebiotic EffecT InfanTs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-17

Study Completion Date

2024-06-30

Brief Summary

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The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on stool consistency in infants.

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Detailed Description

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The fermentation of prebiotic inulin-type fructans leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA). The introduction of solid foods is frequently associated with harder stools which are more difficult to pass and can cause painful defecations. Subsequently, the changes in bowel habits associated with weaning and the introduction of complementary foods could be minimized by the addition of prebiotics to complementary foods and, thus, the transition from milk-feeding to family food could be facilitated.

Conditions

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Infant Development Healthy Diet, Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Prebiotic

Inulin-type fructans

Group Type EXPERIMENTAL

Prebiotic

Intervention Type DIETARY_SUPPLEMENT

Daily intake of Inulin-type fructans from chicory

Placebo

Maltodextrin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Daily intake of maltodextrin

Interventions

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Prebiotic

Daily intake of Inulin-type fructans from chicory

Intervention Type DIETARY_SUPPLEMENT

Placebo

Daily intake of maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Child is healthy at the time of pre-examination
* Child was born on term or preterm (≥ 32 weeks of gestation)
* Child is aged 6-12 months at the time of pre-examination (for preterm born children (32-37 weeks of gestation), corrected age will be applied)
* Normal growth (weight and length for age between 10th and 90th percentiles, Fenton and Kim 2013)
* Child receives at least one meal per day as complementary feeding
* Child and legal guardian are able and willing to follow the study instructions
* Child is suitable for participation in the study according to the investigator/physician/study personnel
* Written informed consent is given by parent or legal guardian

Exclusion Criteria

* No legal guardian's command of any local language
* Organic causes of defecation disorders incl. Hirschsprung disease, Spina bifida, hypothyroidism etc.
* Other metabolic or renal abnormalities or psychomotor retardation (e.g. hypotonia)
* Child has allergy to cow's milk protein or lactose intolerance
* Child has been or is currently breast-fed more than once daily (6 weeks before intervention)
* Child has mostly loose or watery stools in ≥ 50% of defecations
* Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention)
* Use of laxatives or pre- or probiotic supplements in the previous 4 weeks before intervention
* Child is currently involved or will be involved in another clinical or food study

Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ricardo Closa Monasterolo, Phd, MD

Role: PRINCIPAL_INVESTIGATOR

Paediatrics Unit, University Hospital Joan XXIII, Tarragona, Spain. Paediatrics Research Unit on Nutrition and Human Development, Universitat Rovira i Virgili, Reus, Spain

Joaquin Escribano Subias, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Paediatrics Unit, University Hospital Sant Joan, Reus, Spain. Paediatrics Research Unit on Nutrition and Human Development, Universitat Rovira i Virgili, Reus, Spain