Human Milk Oligosaccharide (HMO) Supplementation in Colic Management

NCT05554991 | Terminated

• 1 other identifier: 20.28.INF
• Study Type: interventional
• Target: 5
• Locations: 2 countries
• Sites: 7

Brief Summary

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

Conditions

Colic

Outcome Measures

Primary Outcomes (1)

• 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.

  At the end of the intervention period (day 21)

Secondary Outcomes (29)

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

  V1 (day 0), V2 (day 7), and V4 (day 21)

• Difference in average infant daily crying duration

  Change from baseline (V1) to intervention end (V4)

• Difference in average infant daily fussing duration

  Change from baseline (V1) to intervention end (V4)

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

  Change from baseline (V1) to intervention end (V4)

• Difference in average infant daily crying duration in the Intervention group

  Change from baseline (V1) to intervention end (V4)

Other Outcomes (7)

• Duration and number of episodes of infant crying type based on a crying-type classification of the audio recording

  24 hours after V1 (day 0), V2 (day 7), V3 (day 14) and for 3 days prior to V4 (day 21)

• Proportion of children with a specific crying type based on a crying-type classification of the audio recording

  24 hours after V1 (day 0), V2 (day 7), V3 (day 14) and for 3 days prior to V4 (day 21)

• Duration of crying based on a crying-type classification of the audio recording

  24 hours after V1 (day 0), V2 (day 7), V3 (day 14) and for 3 days prior to V4 (day 21)

Study Arms (2)

Liquid oral supplement comprising HMO

EXPERIMENTAL

2 ampules/day for 21 days

Dietary Supplement: HMO; Behavioral: Parental reassurance and support

Placebo

PLACEBO COMPARATOR

2 ampules/day for 21 days

Dietary Supplement: Placebo; Behavioral: Parental reassurance and support

Interventions

HMO DIETARY_SUPPLEMENT

Composition comprising of HMO

Liquid oral supplement comprising HMO

Placebo DIETARY_SUPPLEMENT

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

Placebo

Parental reassurance and support BEHAVIORAL

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

Liquid oral supplement comprising HMO; Placebo

Eligibility Criteria

• Age: 2 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants 2 weeks - 12 weeks of age at enrolment
• Infants diagnosed with colic according to Rome IV criteria: Diagnostic criteria for research purposes (infant must meet all Rome IV criteria):
• 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
• 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
• No evidence of infant failure to thrive, fever, or illness
• 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
• 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.)
• Term infants (≥ 37 weeks) generally healthy with normal birth weight (≥2.5kg) and singleton born
• 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.
• Infants who have been on the same formula for the past 5 days
• Signed informed consent obtained for infant's and parents'/Legally Acceptable Representative (LAR) participation in the study
• Parent/LAR of infant agrees not to enroll infant in another interventional clinical research study while participating in this study
• Parent of the infant/LAR is willing and able to fulfill the requirements of the study protocol
• 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.

You may not qualify if:

• Presence of any congenital condition and/or previous or current illness/infection and (or) medication use that could interfere with the main study outcomes.
• Clinical evidence of chronic illness or gastrointestinal disorders, major medical problems (e.g. ill, immunocompromised, major developmental or genetic abnormality).
• Known cow's milk protein allergy, lactose intolerance, or galactosaemia; including presence of any allergic manifestations.
• Received any special formula (e.g. lactose-free, hydrolyzed protein) within 5 days before randomization or switched formulas within 5 days before randomization.
• 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
• Other infant(s) \<6months of age living in the same household.
• Current participation in another interventional clinical trial.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (7)

Ospedale Pediatrico Giovanni XXIII, Policlinico di Bari

Bari, 70126, Italy

Location

ASST FBF Sacco

Milan, Italy

Location

AOUP Paolo Giaccone

Palermo, Italy

Location

Azienda Ospedaliero -Universitaria Pisana

Pisa, Italy

Location

Centro de Salud El Ranero

Murcia, 30009, Spain

Location

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Unidad de Estudios e Investigación IHP

Seville, 41014, Spain

Location

MeSH Terms

Conditions

Colic

Interventions

Health Maintenance Organizations; Palliative Care

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Managed Care Programs; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Prepaid Health Plans; Group Practice; Professional Practice; Organization and Administration; Health Services Administration; Delivery of Health Care; Patient Care Management; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization will be carried out using iMedidata Randomization Trial Supply Management System with the dynamic allocation algorithm.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blinded, placebo-controlled, parallel-arm, intervention study

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: September 26, 2022
• Study Start: June 24, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); IT (4)