Clinical trial NCT04791956: Prebiotic EffecT InfanTs
Official title: Double-blind, Randomized Placebo-controlled Trial Investigating the Effect of Prebiotic Inulin-type Fructans on Bowel Habits of Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant Development
Healthy
Diet, Healthy
Keywords: Microbiota, gastrointestinal health
Lead sponsor: Beneo-Institute
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitari Sant Joan de Reus
name: Hospital de Tarragona Joan XXIII
name: Institut Investigacio Sanitaria Pere Virgili
First posted: 2021-03-10
Enrollment: 140
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Stool consistency
timeFrame: 4 weeks
Secondary outcomes:
measure: Stool frequency
timeFrame: 4 weeks
measure: Stool colour
timeFrame: 4 weeks
measure: Stool amount
timeFrame: 4 weeks
measure: Sleep
timeFrame: 4 weeks
measure: Stool pH
timeFrame: 4 weeks
measure: stool short-chain fatty acids
timeFrame: 4 weeks
measure: Tolerance and acceptability
timeFrame: 4 weeks
measure: Body weight
timeFrame: 4 weeks
measure: Body height
timeFrame: 4 weeks
measure: Faecal Microbiota
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus - Magatzem
city: Tarragona
country: Spain
facility: Hospital Universitari Joan XXIII de Tarragona - Almacén general
Study officials:
affiliation: Paediatrics Unit, University Hospital Joan XXIII, Tarragona, Spain. Paediatrics Research Unit on Nutrition and Human Development, Universitat Rovira i Virgili, Reus, Spain
name: Ricardo Closa Monasterolo, Phd, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Paediatrics Unit, University Hospital Sant Joan, Reus, Spain. Paediatrics Research Unit on Nutrition and Human Development, Universitat Rovira i Virgili, Reus, Spain
name: Joaquin Escribano Subias, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Closa-Monasterolo R, Ferre N, Castillejo-DeVillasante G, Luque V, Gispert-Llaurado M, Zaragoza-Jordana M, Theis S, Escribano J. The use of inulin-type fructans improves stool consistency in constipated children. A randomised clinical trial: pilot study. Int J Food Sci Nutr. 2017 Aug;68(5):587-594. doi: 10.1080/09637486.2016.1263605. Epub 2016 Dec 8.