ColicNCT05554991
Human Milk Oligosaccharide (HMO) Supplementation in Colic Management
A study testing HMO and Parental reassurance and support in people with Colic, run by Société des Produits Nestlé (SPN) at 7 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 2 to 12 weeks
- Conditions the study is for
- Colic
- What is being tested?
- HMO and Parental reassurance and support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 24 Jun 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Italy4 sites
Ospedale Pediatrico Giovanni XXIII, Policlinico di Bari
Bari, 70126
ASST FBF Sacco
Milan
AOUP Paolo Giaccone
Palermo
Azienda Ospedaliero -Universitaria Pisana
Pisa
Spain3 sites
Centro de Salud El Ranero
Murcia, 30009
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, 15706
Unidad de Estudios e Investigación IHP
Seville, 41014
About this study
Official title: Efficacy and Tolerability of a Composition Comprising of HMO in a Supplement Format on Colic Management: a Double-blind, Randomized, Placebo-controlled Trial
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.
- Conditions
- Colic
- Being tested
- HMO, Placebo, Parental reassurance and support
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMODietary supplement
Composition comprising of HMO
PlaceboDietary supplement
Placebo supplementation having the same appearance and dosing regimen as the intervention
Parental reassurance and supportBehavioural
Both groups will receive standardized written materials to provide parental reassurance and support, in alignment with local clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Liquid oral supplement comprising HMO | Experimental | 2 ampules/day for 21 days Receives: Dietary Supplement: HMO; Behavioral: Parental reassurance and support |
| Placebo | Placebo comparator | 2 ampules/day for 21 days Receives: Dietary Supplement: Placebo; Behavioral: Parental reassurance and support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Modulation of infant gut microbiota in the intervention group versus the control group assessed using metagenomics
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline (V1) to intervention end (V4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: At specific visits V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21)
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
Measured: V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21)
Overall GI tolerance and individual GI symptoms
Change in IGSQ-13 scores assessed using IGSQ-13
Measured: Baseline to intervention end (day 21)
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
Measured: At V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21)
Overall GI tolerance and individual GI symptoms
Change in CoMiSS scores assessed using CoMiSS
Measured: From baseline to intervention end (day 21)
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)
Measured: 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)
Infant sleep
Infant sleep duration and nighttime wakings per 24 hours assessed using Brief infant sleep questionnaire (BISQ)
Measured: V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21)
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.
Measured: V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21)
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.
Measured: V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21)
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.
Measured: V1 (day 0), V2 (day 7), and V4 (day 21)
Fecal metabolism
Fecal metabolism (pH, organic acids)
Measured: V1 (day 0), V2 (day 7), and V4 (day 21)
Fecal markers of inflammation calprotectin
Inflammation biomarkers calprotectin assessed using ELISA.
Measured: V1 (day 0) and V4 (day 21)
Fecal markers of inflammation lipocalin
Inflammation biomarkers lipocalin assessed using ELISA.
Measured: V1 (day 0) and V4 (day 21)
Infant anthropometry weight
Weight in grams
Measured: V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21)
Infant anthropometry length
Length in cm
Measured: V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21)
Infant anthropometry head circumference
Head circumference in cm
Measured: V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21)
Infant anthropometry weight gain
Weight gain in g/d
Measured: V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21)
Infant anthropometry length gain
Length gain in cm/d
Measured: V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21)
Infant illness and infection and medication usage
Data collected using a calendar-based electronic Infant Illness Diary (IID)
Measured: V1 (day 0) until V4 (day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start24 Jun 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Why it stopped: Impossibility to recruit the targeted population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColicStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, placebo-controlled, parallel-arm, intervention study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554991
- Sponsor's protocol ID
- 20.28.INF
- Status last verified
- Jun 2024
- First submitted
- 28 Mar 2022
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of a Composition Comprising of HMO in a Supplement Format on Colic Management: a Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05554991
- Acronym / sponsor ID
- 20.28.INF
- Conditions
- Colic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Impossibility to recruit the targeted population
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy and tolerability of a composition comprising of HMO in a supplement format on colic management: a double-blind, randomized, placebo-controlled trial
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, placebo-controlled, parallel-arm, intervention study
| Arm | Type | Receives |
|---|---|---|
| Liquid oral supplement comprising HMO | Experimental | Dietary Supplement: HMO, Behavioral: Parental reassurance and support2 ampules/day for 21 days |
| Placebo | Placebo comparator | Dietary Supplement: Placebo, Behavioral: Parental reassurance and support2 ampules/day for 21 days |
Who may qualify
- Ages
- 2 to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- 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):
- 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
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMOComposition comprising of HMO | Dietary supplement | Liquid oral supplement comprising HMO |
| PlaceboPlacebo supplementation having the same appearance and dosing regimen as the intervention | Dietary supplement | Placebo |
| Parental reassurance and supportBoth groups will receive standardized written materials to provide parental reassurance and support, in alignment with local clinical practice | Behavioural | Liquid oral supplement comprising HMO, Placebo |
Primary outcome
Difference in average infant daily crying and fussing duration
Time frame: At the end of the intervention period (day 21)
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.
29 secondary outcomes
Modulation of infant gut microbiota (communities of microbes, their taxonomy, strain composition, diversity, ecology, functionalities, and the metabolites produced)
Time frame: V1 (day 0), V2 (day 7), and V4 (day 21)
Difference in average infant daily crying duration
Time frame: Change from baseline (V1) to intervention end (V4)
Difference in average infant daily fussing duration
Time frame: Change from baseline (V1) to intervention end (V4)
Difference in average infant daily crying and fussing duration in the IG
Time frame: Change from baseline (V1) to intervention end (V4)
Difference in average infant daily crying duration in the Intervention group
Time frame: Change from baseline (V1) to intervention end (V4)
Difference in average infant daily fussing duration in the Intervention group
Time frame: Change from baseline (V1) to intervention end (V4)
Infant daily crying and fussing duration assessed longitudinally
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
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
Time frame: At specific visits V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21)
Incidence of infantile colic
Time frame: At specific visits V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21)
Parental perception of colic severity
Time frame: At specific visits V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21)
Overall GI tolerance and individual GI symptoms
Time frame: V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21)
Overall GI tolerance and individual GI symptoms
Time frame: Baseline to intervention end (day 21)
Overall GI tolerance and individual GI symptoms
Time frame: At V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21)
Overall GI tolerance and individual GI symptoms
Time frame: From baseline to intervention end (day 21)
Overall GI tolerance and individual GI symptoms
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)
Infant sleep
Time frame: V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21)
Infant Quality of life
Time frame: V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21)
Parental and family quality of life
Time frame: V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21)
Infant fecal gut microbiota
Time frame: V1 (day 0), V2 (day 7), and V4 (day 21)
Fecal metabolism
Time frame: V1 (day 0), V2 (day 7), and V4 (day 21)
Fecal markers of inflammation calprotectin
Time frame: V1 (day 0) and V4 (day 21)
Fecal markers of inflammation lipocalin
Time frame: V1 (day 0) and V4 (day 21)
Infant anthropometry weight
Time frame: V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21)
Infant anthropometry length
Time frame: V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21)
Infant anthropometry head circumference
Time frame: V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21)
Infant anthropometry weight gain
Time frame: V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21)
Infant anthropometry length gain
Time frame: V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21)
Infant illness and infection and medication usage
Time frame: V1 (day 0) until V4 (day 21)
Results and safety
The study was stopped early (reason given: Impossibility to recruit the targeted population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMO and Parental reassurance and support in people with Colic, run by Société des Produits Nestlé (SPN) at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Impossibility to recruit the targeted population). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in average infant daily crying and fussing duration (time frame: At the end of the intervention period (day 21)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.