Infantile ColicsPhase 4NCT02708238

Efficacy of Matricariae Chamomilla L., Melissa Officinalis L. and Tyndallized Lactobacillus Acidophilus (H122) for Infantile Colics

A Phase 4 study testing Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122), Lactobacillus reuteri DSM 17938 (108 CFU) and Simethicone in people with Infantile Colics, run by Federico II University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 14 days to 4 months
Conditions the study is for: Infantile Colics
What is being tested?: Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122), Lactobacillus reuteri DSM 17938 (108 CFU) and Simethicone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: No sites listed yet
Study dates: Apr 2014to Jul 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 14 days to 4 months
All sexes
No healthy volunteers
Child

Who may be able to join

diagnosis of IC according to Rome III criteria (2);
age ≥2 weeks to 4 months;
breast-fed or fomula-fed infants;
term delivery (≥37 weeks gestation at birth);
5-minute Apgar score ≥7; and 6) birth weight ≥2500 g

Who cannot join

a major medical problem or acute illness;
family history of atopy;
history of antibiotic treatment before or during the study;
history of probiotic supplementation.

About this study

Official title: Efficacy of a Standardized Extract of Matricariae Chamomilla L., Melissa Officinalis L. and Tyndallized Lactobacillus Acidophilus (H122) Compared With Lactobacillus Reuteri (DSM 17938) and With Simethicone for the Treatment of Infantile Colic

A multicenter prospective, randomized comparative study will be conducted in infants with colic, according to Rome III criteria. Enrolled infants will be assigned at random to receive Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122), L reuteri DSM 17938 (108 CFU) or simethicone. Treatment will be given to subjects for 28 days and they will be followed for 4 weeks. Treatment success will be assessed at the end of study period. Daily crying and fussing times will be recorded in a structured diary, and maternal questionnaires will be completed to monitor changes in infant colic symptoms and adverse events.

Read the detailed description

This will be a prospective, multicentre, open label, randomized, controlled trial. All consecutive infants diagnosed with IC, according to Rome III criteria, will be prospectively enrolled in a 12 months period by 3 different Pediatric Gastroenterology units: Department of Translational Medical Science, Section of Pediatrics, University of Naples "Federico II"; Institute of Pediatrics of the University of Foggia; Endoscopy and Gastroenterology Unit, Department of Pediatrics, University of Messina.

After the enrollment, all children will be randomly assigned to receive Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122) (Group A), L reuteri DSM 17938 (108 CFU) (Group B) or Simethicone (Group C). Treatment will be given to subjects for 28 days. The study's primary outcome is defined as a reduction in the duration of average crying times, from baseline (day 0) to end of treatment (day 28). The secondary outcome measure is the number of participants who respond to treatment on days 28. Infants who experience a decrease in the daily average crying time of 50% from baseline will be considered as responders to the treatment. Parents will be instructed to complete a structured 28-day maternal diary, modified from Barr et al. in order to record the frequency of colic episodes and the daily crying and fussing time (in minutes), feeding schedule, stool frequency and characteristics, and any adverse events experienced (14). Follow-up visits will be conducted on study days 7, 14, 21 and 28 by the same study investigator. At that visit, diaries and unused study products will be returned.

Conditions: Infantile Colics
Being tested: Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122), Lactobacillus reuteri DSM 17938 (108 CFU), Simethicone
Keywords: Infantile colics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)Dietary supplement
Lactobacillus reuteri DSM 17938 (108 CFU)Dietary supplement
SimethiconeDrug

Study groups in NCT02708238
Study group	Role	What they receive
Group A	Experimental	All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution Receives: Dietary Supplement: Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)
Group B	Active comparator	All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension Receives: Dietary Supplement: Lactobacillus reuteri DSM 17938 (108 CFU)
Group C	Active comparator	All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 15 drops two times per day of a commercially available solution Receives: Drug: Simethicone

What is being measured

The primary outcome is the main question the study is designed to answer.

Median Daily Crying Time at the End of the Treatment
Median daily crying at the end of treatment (day 28).
Measured: 28 days of treatment

Secondary outcomes (1)

Number of Responders
Number of responders defined as the number of patients who experienced a decrease in the daily average crying time of 50% from baseline
Measured: 28 days of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Jul 2015

First posted15 Mar 2016 (estimated)
Study startApr 2014
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Infantile ColicsStudies 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02708238
Sponsor's protocol ID: 04032016
Status last verified: Jun 2016
First submitted: 4 Mar 2016
Last updated: 29 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Publication

Publications

Martinelli M, Ummarino D, Giugliano FP, Sciorio E, Tortora C, Bruzzese D, De Giovanni D, Rutigliano I, Valenti S, Romano C, Campanozzi A, Miele E, Staiano A. Efficacy of a standardized extract of Matricariae chamomilla L., Melissa officinalis L. and tyndallized Lactobacillus acidophilus (HA122) in infantile colic: An open randomized controlled trial. Neurogastroenterol Motil. 2017 Dec;29(12). doi: 10.1111/nmo.13145. Epub 2017 Jun 30.
PubMed 28665038

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
The Effect of Probiotics in Infantile Colic
Infantile Colic
Active, not recruiting
Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
Infantile Colic
Recruiting
Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete
Infantile Colics, Constipation
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BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months
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Not yet recruitingObservational study
Validation Of A Parent Administered Symptom Score For Unsettled Infants (Every Baby is UnIQue)
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All Infantile Colics trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of a Standardized Extract of Matricariae Chamomilla L., Melissa Officinalis L. and Tyndallized Lactobacillus Acidophilus (H122) Compared With Lactobacillus Reuteri (DSM 17938) and With Simethicone for the Treatment of Infantile Colic
ClinicalTrials.gov ID: NCT02708238
Acronym / sponsor ID: 04032016
Conditions: Infantile Colics
Keywords: Infantile colics
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Federico II UniversityUniversity, hospital or other
Study start: Apr 2014
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 15 Mar 2016 (estimated)
Results: Posted 29 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group A	Experimental	Dietary Supplement: Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution
Group B	Active comparator	Dietary Supplement: Lactobacillus reuteri DSM 17938 (108 CFU)All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension
Group C	Active comparator	Drug: SimethiconeAll enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 15 drops two times per day of a commercially available solution

Who may qualify

Ages: 14 days to 4 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

diagnosis of IC according to Rome III criteria (2);
age ≥2 weeks to 4 months;
breast-fed or fomula-fed infants;
term delivery (≥37 weeks gestation at birth);
5-minute Apgar score ≥7; and 6) birth weight ≥2500 g

Key exclusion criteria (4 listed)

a major medical problem or acute illness;
family history of atopy;
history of antibiotic treatment before or during the study;
history of probiotic supplementation.

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
Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)	Dietary supplement	Group A
Lactobacillus reuteri DSM 17938 (108 CFU)	Dietary supplement	Group B
Simethicone	Drug	Group C

Primary outcome

Median Daily Crying Time at the End of the Treatment
Time frame: 28 days of treatment
Median daily crying at the end of treatment (day 28).

1 secondary outcome

Number of Responders
Time frame: 28 days of treatment

Results and safety

Results posted to the registry on 29 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A	60	60
Group B	60	59
Group C	60	57

Primary outcome: Median Daily Crying Time at the End of the Treatment

Time frame: 28 days of treatment. Median (Full Range). Unit: minutes

Measure	Group A n = 60	Group B n = 59	Group C n = 57
Value	50 (30 to 180)	55 (30 to 180)	80 (30 to 270)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A	0 of 60 (0%)	0 of 60 (0%)	Not reported
Group B	0 of 59 (0%)	0 of 59 (0%)	Not reported
Group C	0 of 57 (0%)	0 of 57 (0%)	Not reported

Limitations and caveats (from the sponsor): The absence of a placebo group and the open label design represent the main limitations of this study

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28665038Martinelli M, Ummarino D, Giugliano FP, Sciorio E, Tortora C, Bruzzese D, De Giovanni D, Rutigliano I, Valenti S, Romano C, Campanozzi A, Miele E, Staiano A. Efficacy of a standardized extract of Matricariae chamomilla L., Melissa officinalis L. and tyndallized Lactobacillus acidophilus (HA122) in infantile colic: An open randomized controlled trial. Neurogastroenterol Motil. 2017 Dec;29(12). doi: 10.1111/nmo.13145. Epub 2017 Jun 30.
Individual participant dataSharing planned: Yes. Publication

Related trials for Infantile Colics

Recruiting
The Effect of Probiotics in Infantile Colic
Infantile Colic
Active, not recruiting
Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
Infantile Colic
Recruiting
Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete
Infantile Colics, Constipation
Recruiting
BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months
Infantile Colic, Gastroesophageal Reflux (GER)
Not yet recruitingObservational study
Validation Of A Parent Administered Symptom Score For Unsettled Infants (Every Baby is UnIQue)
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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.

Annamaria Staiano, Prof. principal investigator

Federico II University

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 4 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 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Median Daily Crying Time at the End of the Treatment (time frame: 28 days of treatment). 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 NCT02708238, 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 29 Jul 2016.