Infantile ColicPhase 4NCT02430831
Effect of Milk Formula Supplemented With L. Reuteri on Crying Time in Colicky Infants Less Than 3 Months Old
A Phase 4 study testing Nidina in people with Infantile Colic, run by University of Bari at 1 site in Italy.
Trial summary
Study type: Randomized controlled trial with two parallel arms Objectives Primary : Demonstrate that daily supplementation of colicky infants with Nidina formula containing L. reuteri DSM 17938 decreases the daily crying duration at 21 days Secondary : Evaluate the effects of daily supplementation of colicky infants… Read more about this study
- Who is it for?
- Ages Up to 12 weeks
- Conditions the study is for
- Infantile Colic
- What is being tested?
- Nidina
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- May 2015to May 2016
- Phase
- Phase 4
- 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 Up to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- less then 12 weeks of age
- term infant (≥ 38 weeks gestational age)
- birth weight > 2,500g
- infantile colic diagnosed according to modified Wessel's criteria, i.e. crying more than an average of 180 min/day during the 3 days prior to enrollment.
- parental motivation to postpone changes in the infant feeding mode, unles
Who cannot join
- - birth weight less than 2500 g
- failure to thrive
- chronic illness or major medical problem
- gastrointestinal disease
- cow's milk allergy ( confirmed prior to exclusion; difficult to diagnose so early ??)
- use of any antibiotic or probiotic in the week (7 days) prior to enrollment
Show all 10Show fewer
- use of proton pump inhibitors in the week (7 days) prior to enrollment
- if breastfeeding, use of probiotic by the mother in the week (7 days) prior to enrollment
- infant receiving solid foods (such as cereals, mashed fruits or vegetable purée)
- change of feeding mode planned by parents during the study period
Trial locations and contacts
1 site in 1 country.
Flavia Indrio, MD contact
About this study
Official title: Randomized Controlled Trial Testing the Effect of Milk Formula Supplemented With L. Reuteri on Crying Time in Colicky Infants Less Than 3 Months Old
Study type:
Randomized controlled trial with two parallel arms Objectives
Primary : Demonstrate that daily supplementation of colicky infants with Nidina formula containing L. reuteri DSM 17938 decreases the daily crying duration at 21 days Secondary : Evaluate the effects of daily supplementation of colicky infants with Nidina formula containing L. reuteri DSM 17938 measured as
- the number of "responders" or the "treatment success" (ie infants for which defined as the percentage of children achieving a reduction in the daily average crying time >50% in 3 weeks. (day 1 to day 21 of the study)
- maternal depression and family functioning scoring
Read the detailed description
Inclusion criteria :
- less then 12 weeks of age
- term infant (≥ 38 weeks gestational age)
- birth weight > 2,500g
- infantile colic diagnosed according to modified Wessel's criteria, i.e. crying more than an average of 180 min/day during the 3 days prior to enrollment.
- parental motivation to postpone changes in the infant feeding mode, unless necessary
Exclusion criteria:
- birth weight less than 2500 g
- failure to thrive
- chronic illness or major medical problem
- gastrointestinal disease
- cow's milk allergy ( confirmed prior to exclusion; difficult to diagnose so early ??)
- use of any antibiotic or probiotic in the week (7 days) prior to enrollment
- use of proton pump inhibitors in the week (7 days) prior to enrollment
- if breastfeeding, use of probiotic by the mother in the week (7 days) prior to enrollment
- infant receiving solid foods (such as cereals, mashed fruits or vegetable purée)
- change of feeding mode planned by parents during the study period
Randomization and blinding: to be written by the CRO, according to its own procedures.
Extreme caution should be given to blinding. Methods should give full certainty that blinding was perfect at the subject (parent) level, but also at the pediatrician and with all involved personnel.
Randomization should be done according to 3 feeding modes :
- "breast feeding: only breast, except for 2 bottle feedings a week,
- "formula fed": only formula except two breast feeding a week,
- "mixed feeding": all the remaining
- Conditions
- Infantile Colic
- Being tested
- Nidina, Placebo
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NidinaDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Reuteri group | Active comparator | Milk formula added with probiotic L reuterii DSM 17938 Receives: Dietary Supplement: Nidina |
| Placebo | Placebo comparator | Milk formula without probiotic L reuterii DSM 17938 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Crying duration
The average crying time in minutes per day measured on day 19, 20, and 21 between active and placebo groups.
Measured: three days
Secondary outcomes (3)
Rate of success (decrease in mean daily crying time)
Percentage of infants in the active group compared to the placebo group in whom the mean of daily crying time of the days 19, 20 and 21 decreased by 50% compared to the three days prior to recruitment.
Measured: 3 days
Family functional score (family functioning scale)
The score achieved in the family functioning scale at day 21.
Measured: one day
Mother depression (mother depression Scale)
The score achieved in the mother depression Scale at day 21.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile ColicStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Collaborators
- Antonio Di Mauro, Ruggiero Francavilla, Lorenzo Trovè
- Responsible party
- Principal investigator, Flavia Indrio, University of Bari
- Investigators
- Flavia Indrio, MD, Principal investigator, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430831
- Sponsor's protocol ID
- VF/FC
- Status last verified
- Apr 2015
- First submitted
- 31 Mar 2015
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Testing the Effect of Milk Formula Supplemented With L. Reuteri on Crying Time in Colicky Infants Less Than 3 Months Old
- ClinicalTrials.gov ID
- NCT02430831
- Acronym / sponsor ID
- VF/FC
- Conditions
- Infantile Colic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BariUniversity, hospital or other
- Collaborators
- Antonio Di Mauro, Ruggiero Francavilla, Lorenzo Trovè
- Study start
- May 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 30 Apr 2015 (estimated)
- 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.
Study type:
Randomized controlled trial with two parallel arms Objectives
Primary : Demonstrate that daily supplementation of colicky infants with Nidina formula containing L. reuteri DSM 17938 decreases the daily crying duration at 21 days Secondary : Evaluate the effects of daily supplementation of colicky infants with Nidina formula containing L. reuteri DSM 17938 measured as
- the number of "responders" or the "treatment success" (ie infants for which defined as the percentage of children achieving a reduction in the daily average crying time >50% in 3 weeks. (day 1 to day 21 of the study)
- maternal depression and family functioning scoring
Detailed description
Inclusion criteria :
- less then 12 weeks of age
- term infant (≥ 38 weeks gestational age)
- birth weight > 2,500g
- infantile colic diagnosed according to modified Wessel's criteria, i.e. crying more than an average of 180 min/day during the 3 days prior to enrollment.
- parental motivation to postpone changes in the infant feeding mode, unless necessary
Exclusion criteria:
- birth weight less than 2500 g
- failure to thrive
- chronic illness or major medical problem
- gastrointestinal disease
- cow's milk allergy ( confirmed prior to exclusion; difficult to diagnose so early ??)
- use of any antibiotic or probiotic in the week (7 days) prior to enrollment
- use of proton pump inhibitors in the week (7 days) prior to enrollment
- if breastfeeding, use of probiotic by the mother in the week (7 days) prior to enrollment
- infant receiving solid foods (such as cereals, mashed fruits or vegetable purée)
- change of feeding mode planned by parents during the study period
Randomization and blinding: to be written by the CRO, according to its own procedures.
Extreme caution should be given to blinding. Methods should give full certainty that blinding was perfect at the subject (parent) level, but also at the pediatrician and with all involved personnel.
Randomization should be done according to 3 feeding modes :
- "breast feeding: only breast, except for 2 bottle feedings a week,
- "formula fed": only formula except two breast feeding a week,
- "mixed feeding": all the remaining
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reuteri group | Active comparator | Dietary Supplement: NidinaMilk formula added with probiotic L reuterii DSM 17938 |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMilk formula without probiotic L reuterii DSM 17938 |
Who may qualify
- Ages
- Up to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- less then 12 weeks of age
- term infant (≥ 38 weeks gestational age)
- birth weight > 2,500g
- infantile colic diagnosed according to modified Wessel's criteria, i.e. crying more than an average of 180 min/day during the 3 days prior to enrollment.
- parental motivation to postpone changes in the infant feeding mode, unles
Key exclusion criteria (10 listed)
- - birth weight less than 2500 g
- failure to thrive
- chronic illness or major medical problem
- gastrointestinal disease
- cow's milk allergy ( confirmed prior to exclusion; difficult to diagnose so early ??)
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 |
|---|---|---|
| Nidina | Dietary supplement | Reuteri group |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Daily Crying duration
Time frame: three days
The average crying time in minutes per day measured on day 19, 20, and 21 between active and placebo groups.
3 secondary outcomes
Rate of success (decrease in mean daily crying time)
Time frame: 3 days
Family functional score (family functioning scale)
Time frame: one day
Mother depression (mother depression Scale)
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
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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.
Flavia Indrio, MD contact
Flavia Indrio, MD principal investigator
University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nidina in people with Infantile Colic, run by University of Bari 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 30 Apr 2015. 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. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Flavia Indrio, MD (f.indrio@alice.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Crying duration (time frame: three days). 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 30 Apr 2015.