Human Milk Oligosaccharide (HMO) Supplementation in Colic Management

Société des Produits Nestlé (SPN)5 enrolled

Overview

Efficacy and tolerability of a composition comprising of HMO in a supplement format on colic management: a double-blind, randomized, placebo-controlled trial

This is a double-blinded, randomized, placebo-controlled trial. The purpose of this trial is to investigate the efficacy and tolerability of a composition comprising of HMO in a supplement format in the management of colicky infants aged 2-12 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Colic

Interventions

HMODIETARY_SUPPLEMENT

Composition comprising of HMO

PlaceboDIETARY_SUPPLEMENT

Placebo supplementation having the same appearance and dosing regimen as the intervention

Parental reassurance and supportBEHAVIORAL

Both groups will receive standardized written materials to provide parental reassurance and support, in alignment with local clinical practice

Eligibility

Sex: ALLMin age: 2 WeeksMax age: 12 Weeks

Medical Language ↔ Plain English

Inclusion criteria: 1. Infants 2 weeks - 12 weeks of age at enrolment 2. Infants diagnosed with colic according to Rome IV criteria: Diagnostic criteria for research purposes (infant must meet all Rome IV criteria): 1. An infant who is less than 5 months of age (in the current clinical trial, only infants 2 weeks to 8 weeks of age will be enrolled) when the symptoms start and stop 2. Recurrent and prolonged periods of infant crying, fussing, or irritability reported by caregivers that occur without obvious cause and cannot be prevented or resolved by caregivers 3. No evidence of infant failure to thrive, fever, or illness 4. Excessive crying/fussiness for 3 or more hours per day during 3 or more days in the past 7 days as reported by parents to the clinician 5. Total 24-hour crying plus fussing is 3 hours or more when measured by at least one prospectively kept 24-hour behavior diary. (The Structured Infant Crying and Fussing Diary will be dispensed at the screening visit (V0), completed for two 24-hour periods at H0 (days -3 to -1), and returned at V1 to be used as part of the diagnostic criteria for infantile colic.) 3. Term infants (≥ 37 weeks) generally healthy with normal birth weight (≥2.5kg) and singleton born 4. Predominantly formula fed\* (formula fed ≥ 80% of the time) for at least 7 days before randomization and the choice of formula feeding has been made by the parents before the beginning of the trial. 5. Infants who have been on the same formula for the past 5 days 6. Signed informed consent obtained for infant's and parents'/Legally Acceptable Representative (LAR) participation in the study 7. Parent/LAR of infant agrees not to enroll infant in another interventional clinical research study while participating in this study 8. Parent of the infant/LAR is willing and able to fulfill the requirements of the study protocol 9. Parent of infant can be contacted throughout the study * Predominantly formula feeding defined in the study means that the infant's predominant source of nourishment is formula. Specifically, infants are fed with formula for at least 80% of total milk feeds per day. Exclusion criteria: 1. Presence of any congenital condition and/or previous or current illness/infection and (or) medication use that could interfere with the main study outcomes. 2. Clinical evidence of chronic illness or gastrointestinal disorders, major medical problems (e.g. ill, immunocompromised, major developmental or genetic abnormality). 3. Known cow's milk protein allergy, lactose intolerance, or galactosaemia; including presence of any allergic manifestations. 4. Received any special formula (e.g. lactose-free, hydrolyzed protein) within 5 days before randomization or switched formulas within 5 days before randomization. 5. Received any of the following products/medication within 5 days before randomization: * Antibiotics * Alginate * Prokinetics * Proton pump inhibitors * Simethicone * L. reuteri probiotic * Formula containing Human milk Oligosaccharides 6. Other infant(s) \<6months of age living in the same household. 7. Current participation in another interventional clinical trial.

Locations (7)

Ospedale Pediatrico Giovanni XXIII, Policlinico di Bari

Bari, Italy

ASST FBF Sacco

Milan, Italy

AOUP Paolo Giaccone

Palermo, Italy

Azienda Ospedaliero -Universitaria Pisana

Pisa, Italy

Outcomes

Primary Outcomes

Difference in average infant daily crying and fussing duration

Difference in average infant daily crying and fussing duration at the end of the intervention in the Intervention Group (IG) versus the Control Group (CG). The crying and fussing duration is measured using a structured infant crying and fussing diary.

Time frame: At the end of the intervention period (day 21)

Secondary Outcomes

Modulation of infant gut microbiota (communities of microbes, their taxonomy, strain composition, diversity, ecology, functionalities, and the metabolites produced)

Modulation of infant gut microbiota in the intervention group versus the control group assessed using metagenomics

Time frame: V1 (day 0), V2 (day 7), and V4 (day 21)

Difference in average infant daily crying duration

Difference in average infant daily crying duration at the end of the intervention in the IG versus the CG assessed using a structured infant crying and fussing diary.

Time frame: Change from baseline (V1) to intervention end (V4)

Difference in average infant daily fussing duration

Difference in average infant daily fussing duration at the end of the intervention in the IG versus the CG assessed using a structured infant crying and fussing diary.

Time frame: Change from baseline (V1) to intervention end (V4)

Difference in average infant daily crying and fussing duration in the IG

Difference in average infant daily crying duration and fussing duration combined from baseline (V1) to intervention end (V4) in the IG assessed using a structured infant crying and fussing diary.

Time frame: Change from baseline (V1) to intervention end (V4)

Difference in average infant daily crying duration in the Intervention group

Data from ClinicalTrials.gov

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Centro de Salud El Ranero

Murcia, Spain

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Unidad de Estudios e Investigación IHP

Seville, Spain

Difference in average infant daily crying duration from baseline (V1) to intervention end (V4) in the Intervention group assessed using a structured infant crying and fussing diary.

Time frame: Change from baseline (V1) to intervention end (V4)

Difference in average infant daily fussing duration in the Intervention group

Difference in average infant daily fussing duration from baseline (V1) to intervention end (V4) in the interventional group assessed using a structured infant crying and fussing diary.

Time frame: Change from baseline (V1) to intervention end (V4)

Infant daily crying and fussing duration assessed longitudinally

Infant daily crying and fussing duration combined assessed longitudinally across the intervention assessed using a structured infant crying and fussing diary.

Time frame: Longitudinal changes across specific visits V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21)

Infant crying/fussing per 24 hours

Episodes of infant crying/fussing per 24 hours assessed using a structured infant crying and fussing diary.

Time frame: At specific visits V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21)

Percentage of children achieving a reduction in daily crying and fussing

Percentage of children achieving a reduction in daily crying, fussing, crying and fussing time combined of ≤ 25 % and ≤ 50 % assessed using a structured infant crying and fussing diary.

Time frame: At specific visits V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21)

Incidence of infantile colic

Incidence of infantile colic assessed using a structured infant crying and fussing diary.

Time frame: At specific visits V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21)

Parental perception of colic severity

Parental perception of colic severity assessed using a 10-cm visual analog scale (VAS)

Time frame: At specific visits V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21)