Infant ColicNCT06458881
EFFICACY OF A MIXTURE OF SIMETHICONE AND TYNDALLIZED BACILLUS COAGULANS IN INFANT COLIC: A PILOT STUDY
An observational study of Infant Colic, run by Federico II University at 1 site in Italy.
Trial summary
: A pilot study was conducted on a group of 41 infants with diagnosis of Infant Colic according to Rome IV criteria. We administered to all the enrolled infants a mixture of Tyndallized bacillus coagulans and Simethicone for 28 days. The primary outcome was the mean infant crying duration at 28th day. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Infant Colic
- What is being tested?
- Mixture of Simethicone and Tyndallized Bacillus Coagulans
- Type of treatment
- Injection or infusion
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2023to 28 Feb 2024
- Phase
- Observational
- 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 1 month to 12 months
- All sexes
- Child
Study population: Sample size determination was guided by the primary objective of the study and was based on the approach described in Sung et al. (12), using data subsequently published in Sung et al. (13). Specifically, we considered as a comparison base, and as a proxy for a physiological reduction in crying, the success rate (defined as a reduction in crying time by at least 50%) in the placebo group, which Sung et al. (13) reported to be 39%. In comparison, the success rate observed in subjects treated with probiotics was 66%. Therefore, a sample size of 37 subjects was found sufficient to achieve 90% power to detect a success rate of 0.66 (assuming under the null hypothesis a proportion of 0.39), using a two-sided exact test with a 5% significance level. Considering a dropout rate of 10%, 41 patients were enrolled.
Who may be able to join
- Inclusion criteria were: full term infants (>_37 weeks gestation at birth; 5-min Apgar score >_7; Birth weight >_2500 g), aged <12 months, diagnosed with IC according to Rome IV criteria [1], breast- and formulafed infants.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
: A pilot study was conducted on a group of 41 infants with diagnosis of Infant Colic according to Rome IV criteria. We administered to all the enrolled infants a mixture of Tyndallized bacillus coagulans and Simethicone for 28 days. The primary outcome was the mean infant crying duration at 28th day. The secondary outcome was the improvement in the quality of sleep and infants' and parents' quality of life
Read the detailed description
This pilot study is a prospective study coordinated by the Department of Translational Medicine, Section of Pediatrics, University of Naples "Federico II", whereas infants were recruited by 8 general pediatricians belonging to the Pediatrics Investigator Committee of Campania Region, Italy. Inclusion criteria were: full term infants (>_37 weeks gestation at birth; 5-min Apgar score >_7; Birth weight >_2500 g), aged <12 months, diagnosed with IC according to Rome IV criteria [1], breast- and formulafed infants. The parents of the infants participating in the study were supplied with the mixture of Tyndallized B. Coagulans and Simethicone. The Institutional Review Board of Campania 3 approved the research protocol. All parents gave written informed consent. Enrolled infants were treated for 28 days with a mixture of Tyndallized B. Coagulans and Simethicone: 20 drops, four times a day. At enrolment, clinical and dietary history, obstetrical data and anthropometry were recorded. The subjects were classified as having IC based on their parents' responses to the validated questionnaires regarding IC according to Rome IV criteria. The parents were also asked to fill in the following questionnaires: 1) Baby's Day Diary on daily crying and infant sleep duration [21]; 2) a scale (visual analogue scale, VAS, 0e10) for parents' quality of life, a questionnaire on infant's quality of life; 3) a form for stool frequency and consistency; 4) a scale for parental perception of colic severity (VAS 0e10) and 5) a scale for parental perception of sleep quality (VAS 0 e10). Infants were evaluated by a physician for follow-up visits at week 4. During the visits, physical examination was performed and information regarding drugs administration, number and site of infections and eventual adverse medical events were recorded. Moreover, parents had to fill: 3) the questionnaire on infant's quality of life; 4) a review of stool frequency and consistency; 5) the parental perception of colic severity (VAS 0e10) and 6) the parental perception of sleep quality (VAS 0e10). All the authors had access to the study data. Compliance was assessed by evaluating the diary provided by the parents.
Outcomes The primary endpoint was the infant crying duration at 28 days. Treatment success was defined as at least 50% reduction in crying time from baseline to day 28 postintervention. Secondary endpoints included: infant sleep duration at 28 days post-intervention, mean scores on a standardized measure of parents' and infants' quality of life, changes in stool consistency, number of episodes of infant colic per day, parental perception of colic severity (VAS 0-10), parental perception of quality of life (VAS0-10).
- Conditions
- Infant Colic
- Being tested
- Mixture of Simethicone and Tyndallized Bacillus Coagulans
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixture of Simethicone and Tyndallized Bacillus CoagulansCombination product
. Enrolled infants were treated for 28 days with a mixture of Tyndallized B. Coagulans and Simethicone: 20 drops, four times a day. At enrolment, clinical and dietary history, obstetrical data and anthropometry were recorded. The subjects were classified as having IC based on their parents' responses to the validated questionnaires regarding IC according to Rome IV criteria.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint was the infant crying duration at 28 days.
Measured: reatment success was defined as at least 50% reduction in crying time from baseline to day 28 postintervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Jul 2023
- Primary completion1 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant ColicStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Russo, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458881
- Sponsor's protocol ID
- 196/2023
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saviano M, Russo M, Buono P, La Pietra M, Sorrentino E, Chianese A, Ementato S, Illiano G, Napolitano G, Dolce P, Staiano A. Efficacy of a mixture of simethicone and tyndallized bacillus coagulans in infant colic: a pilot study on behalf of Italian Society of Pediatrics (SIP). Ital J Pediatr. 2025 Nov 12;51(1):300. doi: 10.1186/s13052-025-02140-2.
PubMed 41225617
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 OF A MIXTURE OF SIMETHICONE AND TYNDALLIZED BACILLUS COAGULANS IN INFANT COLIC: A PILOT STUDY
- ClinicalTrials.gov ID
- NCT06458881
- Acronym / sponsor ID
- 196/2023
- Conditions
- Infant Colic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 14 Jun 2024 (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.
: A pilot study was conducted on a group of 41 infants with diagnosis of Infant Colic according to Rome IV criteria. We administered to all the enrolled infants a mixture of Tyndallized bacillus coagulans and Simethicone for 28 days. The primary outcome was the mean infant crying duration at 28th day. The secondary outcome was the improvement in the quality of sleep and infants' and parents' quality of life
Detailed description
This pilot study is a prospective study coordinated by the Department of Translational Medicine, Section of Pediatrics, University of Naples "Federico II", whereas infants were recruited by 8 general pediatricians belonging to the Pediatrics Investigator Committee of Campania Region, Italy. Inclusion criteria were: full term infants (>_37 weeks gestation at birth; 5-min Apgar score >_7; Birth weight >_2500 g), aged <12 months, diagnosed with IC according to Rome IV criteria [1], breast- and formulafed infants. The parents of the infants participating in the study were supplied with the mixture of Tyndallized B. Coagulans and Simethicone. The Institutional Review Board of Campania 3 approved the research protocol. All parents gave written informed consent. Enrolled infants were treated for 28 days with a mixture of Tyndallized B. Coagulans and Simethicone: 20 drops, four times a day. At enrolment, clinical and dietary history, obstetrical data and anthropometry were recorded. The subjects were classified as having IC based on their parents' responses to the validated questionnaires regarding IC according to Rome IV criteria. The parents were also asked to fill in the following questionnaires: 1) Baby's Day Diary on daily crying and infant sleep duration [21]; 2) a scale (visual analogue scale, VAS, 0e10) for parents' quality of life, a questionnaire on infant's quality of life; 3) a form for stool frequency and consistency; 4) a scale for parental perception of colic severity (VAS 0e10) and 5) a scale for parental perception of sleep quality (VAS 0 e10). Infants were evaluated by a physician for follow-up visits at week 4. During the visits, physical examination was performed and information regarding drugs administration, number and site of infections and eventual adverse medical events were recorded. Moreover, parents had to fill: 3) the questionnaire on infant's quality of life; 4) a review of stool frequency and consistency; 5) the parental perception of colic severity (VAS 0e10) and 6) the parental perception of sleep quality (VAS 0e10). All the authors had access to the study data. Compliance was assessed by evaluating the diary provided by the parents.
Outcomes The primary endpoint was the infant crying duration at 28 days. Treatment success was defined as at least 50% reduction in crying time from baseline to day 28 postintervention. Secondary endpoints included: infant sleep duration at 28 days post-intervention, mean scores on a standardized measure of parents' and infants' quality of life, changes in stool consistency, number of episodes of infant colic per day, parental perception of colic severity (VAS 0-10), parental perception of quality of life (VAS0-10).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Age groups
- Child
- Study population
- Sample size determination was guided by the primary objective of the study and was based on the approach described in Sung et al. (12), using data subsequently published in Sung et al. (13). Specifically, we considered as a comparison base, and as a proxy for a physiological reduction in crying, the success rate (defined as a reduction in crying time by at least 50%) in the placebo group, which Sung et al. (13) reported to be 39%. In comparison, the success rate observed in subjects treated with probiotics was 66%. Therefore, a sample size of 37 subjects was found sufficient to achieve 90% power to detect a success rate of 0.66 (assuming under the null hypothesis a proportion of 0.39), using a two-sided exact test with a 5% significance level. Considering a dropout rate of 10%, 41 patients were enrolled.
Key inclusion criteria (1 listed)
- Inclusion criteria were: full term infants (>_37 weeks gestation at birth; 5-min Apgar score >_7; Birth weight >_2500 g), aged <12 months, diagnosed with IC according to Rome IV criteria [1], breast- and formulafed infants.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Mixture of Simethicone and Tyndallized Bacillus Coagulans. Enrolled infants were treated for 28 days with a mixture of Tyndallized B. Coagulans and Simethicone: 20 drops, four times a day. At enrolment, clinical and dietary history, obstetrical data and anthropometry were recorded. The subjects were classified as having IC based on their parents' responses to the validated questionnaires regarding IC according to Rome IV criteria. | Combination product | – |
Primary outcome
The primary endpoint was the infant crying duration at 28 days.
Time frame: reatment success was defined as at least 50% reduction in crying time from baseline to day 28 postintervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Derived from this study: PubMed 41225617Saviano M, Russo M, Buono P, La Pietra M, Sorrentino E, Chianese A, Ementato S, Illiano G, Napolitano G, Dolce P, Staiano A. Efficacy of a mixture of simethicone and tyndallized bacillus coagulans in infant colic: a pilot study on behalf of Italian Society of Pediatrics (SIP). Ital J Pediatr. 2025 Nov 12;51(1):300. doi: 10.1186/s13052-025-02140-2.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Colic, run by Federico II University at 1 site in Italy.
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 1 inclusion and 1 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: finished, 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 1 site in Italy. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint was the infant crying duration at 28 days. (time frame: reatment success was defined as at least 50% reduction in crying time from baseline to day 28 postintervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06458881, which also lists 1 linked publication.
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.