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TerminatedNCT05554991Updated Jun 14, 2024

Human Milk Oligosaccharide (HMO) Supplementation in Colic Management

An interventional study of HMO and Placebo in Colic, sponsored by Société des Produits Nestlé (SPN). Terminated at 7 sites in 2 countries. Open to participants aged 2 Weeks to 12 Weeks. Per ClinicalTrials.gov, last updated 2024-06-14.

Sponsored by Société des Produits Nestlé (SPN) (part of Nestlé S.A.) · Not applicable, Interventional, and Other

Why this study was terminated
Impossibility to recruit the targeted population
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
2 Weeks to 12 Weeks
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Colic

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03

In context

Colic

127 studies on the registry are indexed under Colic; 18 are open to participants now.

This study's enrollment of 5 is below the median of 76 across 110 interventional studies indexed under Colic.

Browse Colic studies →

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 324 studies on the registry; 16 are open to participants now.

Browse Société des Produits Nestlé (SPN) studies →All Nestlé S.A. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Weeks to 12 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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, , 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Liquid oral supplement comprising HMO

    2 ampules/day for 21 days

    Dietary Supplement: HMO · Behavioral: Parental reassurance and support

  • Placebo comparator
    Placebo

    2 ampules/day for 21 days

    Dietary Supplement: Placebo · Behavioral: Parental reassurance and support

Interventions

  • Dietary supplementHMO

    Composition comprising of HMO

  • Dietary supplementPlacebo

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

  • BehavioralParental reassurance and support

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

06

What researchers measure

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.

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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. Difference in average infant daily crying duration in the Intervention group

    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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. Overall GI tolerance and individual GI symptoms

    Overall infant GI tolerance and individual GI and GI-related symptoms (stooling, spitup/ vomiting, gassiness, crying, fussiness) assessed using IGSQ-13

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

  13. Overall GI tolerance and individual GI symptoms

    Change in IGSQ-13 scores assessed using IGSQ-13

    Time frame: Baseline to intervention end (day 21)

  14. Overall GI tolerance and individual GI symptoms

    Functional GI symptoms (regurgitation, consistency of stools), crying, allergic symptoms (atopic eczema) and respiratory symptoms assessed using CoMiSS

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

  15. Overall GI tolerance and individual GI symptoms

    Change in CoMiSS scores assessed using CoMiSS

    Time frame: From baseline to intervention end (day 21)

  16. Overall GI tolerance and individual GI symptoms

    Stool consistency, spitting up/vomiting and flatulence assessed using 1-day retrospective GI diary at V1 (day 0) and prospective 3-Day GI symptom diary diaries at home (H2, H3 and H4) just prior to V2 (day 7), V3 (day 14) and V4 (day 21)

    Time frame: 1-day retrospective GI diary at V1 (day 0) and prospective 3-Day GI symptom diary diaries at home (H2, H3 and H4) just prior to V2 (day 7), V3 (day 14) and V4 (day 21)

  17. Infant sleep

    Infant sleep duration and nighttime wakings per 24 hours assessed using Brief infant sleep questionnaire (BISQ)

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

  18. Infant Quality of life

    Infant quality of life assessed using an Infant Quality of Life instrument. The tool includes IQI includes questions on 7 health items such as sleeping, crying, feeding , skin, breathing, playfulness and Interaction, and stooling. Each item consists of 4 levels, most of which are ranked by severity.

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

  19. Parental and family quality of life

    Parental/family quality of life will be assessed using a Quality of Life Visual Analog Scale that rates the parent / family's quality of life based on a 10-point Likert scale.

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

  20. Infant fecal gut microbiota

    Microbiome of fecal samples to investigate the communities of microbes, their taxonomy, strain composition, diversity, ecology, functionalities, and the metabolites produced assessed using metagenomics.

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

  21. Fecal metabolism

    Fecal metabolism (pH, organic acids)

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

  22. Fecal markers of inflammation calprotectin

    Inflammation biomarkers calprotectin assessed using ELISA.

    Time frame: V1 (day 0) and V4 (day 21)

  23. Fecal markers of inflammation lipocalin

    Inflammation biomarkers lipocalin assessed using ELISA.

    Time frame: V1 (day 0) and V4 (day 21)

  24. Infant anthropometry weight

    Weight in grams

    Time frame: V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21)

  25. Infant anthropometry length

    Length in cm

    Time frame: V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21)

  26. Infant anthropometry head circumference

    Head circumference in cm

    Time frame: V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21)

  27. Infant anthropometry weight gain

    Weight gain in g/d

    Time frame: V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21)

  28. Infant anthropometry length gain

    Length gain in cm/d

    Time frame: V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21)

  29. Infant illness and infection and medication usage

    Data collected using a calendar-based electronic Infant Illness Diary (IID)

    Time frame: V1 (day 0) until V4 (day 21)

Other outcomes

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

    Duration and number of episodes of each infant crying type (pain, fussiness, hunger) based on a crying-type classification of the audio recording

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

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

    Proportion of children with a specific crying type (pain, fussiness, hunger) based on a crying-type classification of the audio recording

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

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

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

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

  4. Duration of fussing based on a crying-type classification of the audio recording

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

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

  5. Duration of crying and fussing combined based on a crying-type classification of the audio recording

    Duration of crying and fussing combined based on a crying-type classification of the audio recording

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

  6. Crying and fussing comparison between the structured infant crying and fussing diary and the crying-type classification of the recording of infant crying/fussing across the intervention

    Infant daily crying and fussing duration compared between the structured infant crying and fussing diary and the crying-type classification of the recording of infant crying/fussing across the intervention

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

  7. Maternal Postpartum depression/ anxiety

    Maternal postpartum depressive and anxiety symptoms assessed using an Edinburgh postnatal depression scale (EPDS)

    Time frame: V1 (day 0) and V4 (day 21)

07

Study locations

7 sites
  • Ospedale Pediatrico Giovanni XXIII, Policlinico di Bari
    Bari, 70126, Italy
  • ASST FBF Sacco
    Milano, Italy
  • AOUP Paolo Giaccone
    Palermo, Italy
  • Azienda Ospedaliero -Universitaria Pisana
    Pisa, Italy
  • Centro de Salud El Ranero
    Murcia, 30009, Spain
  • Hospital Clínico Universitario de Santiago de Compostela
    Santiago de Compostela, 15706, Spain
  • Unidad de Estudios e Investigación IHP
    Sevilla, 41014, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2022 to primary completion in Apr 2024, 22 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2022
First posted
Sep 26, 2022
StartActual
Jun 24, 2022
Primary completionActual
Apr 30, 2024
CompletionActual
Apr 30, 2024
Last update
Jun 14, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05554991
Lead sponsor
Société des Produits Nestlé (SPN)
Responsible party
Sponsor
First posted
Sep 26, 2022
Start date
Jun 24, 2022
Primary completion
Apr 30, 2024
Completion
Apr 30, 2024
Last update
Jun 14, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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