ColicPhase 2PROCOLINNCT05198700
The Effect of Probiotics on Symptoms of Infantile Colic
A Phase 2 study testing Probiotic Formulation in people with Colic, run by Lallemand Health Solutions at 5 sites in Spain.
Trial summary
The aim of this study is to evaluate the effects of a probiotic formulation on the daily crying patterns of infants. It is hypothesized that participants given the probiotic formulation will show a significant reduction in daily crying duration compared to participants receiving the placebo. Read more about this study
- Who is it for?
- Ages Up to 8 weeks
- Conditions the study is for
- Colic
- What is being tested?
- Probiotic Formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 5 sitesSpain
- Study dates
- 8 Feb 2022to Feb 2024
- Phase
- Phase 2
- 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 8 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy male or female.
- Age ≤ 8 weeks old.
- Diagnosis of infantile colic according to the Rome IV criteria. Infants must show cry or fuss behaviour for 3 or more hours per day, during 3 or more days in 7 days.
- Exclusively breastfeeding and planning to breastfeed for duration of study.
- With a written informed consent signed by the father, mother, or legal guardian, and with expressed or implied consent of the other parent.
- With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits and telephone calls.
Who cannot join
- Birthweight < 2500 g.
- Gestational age < 37 weeks.
- Apgar score at 5 minutes < 7.
- Partially or fully formula fed infants, with the exception of the first 4 days after birth.
- Stunted growth/weight loss (< 100 g/week from birth to last reported).
- Gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases or gastrointestinal malformations.
Show all 16Show fewer
- Fever and/or infectious diseases, or current systemic infections, or history of congenital infections.
- Genetic diseases and chromosomal abnormalities.
- Metabolic diseases or pancreatic insufficiency.
- Immunodeficiency.
- Neurological diseases.
- Suspected or confirmed food allergies and intolerances.
- Use of probiotics, prebiotics, antibiotics, or gastric acid inhibitors by the infant at any time from birth to the moment of screening.
- Use of anti-colic medication at any time from birth to the moment of screening.
- Use of probiotic supplements by the mother between the birth of their infant and the moment of screening.
- Currently enrolled in another clinical study or having participated in another clinical trial from birth to the moment of screening.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Centro de Salud Ibiza
Madrid, 28009
Hospital Vithas La Milagrosa
Madrid, 28010
Centro de Salud Campo de la Paloma
Madrid, 28018
Hospital Vithas Aravaca
Madrid, 28023
Centro de Salud Cerro del Aire
Majadahonda, Madrid, 28220
About this study
Official title: The Effect of a Probiotic on Symptoms of Infantile Colic: a Randomized, Double-blind, Placebo-controlled Study (PROCOLIN)
The aim of this study is to evaluate the effects of a probiotic formulation on the daily crying patterns of infants. It is hypothesized that participants given the probiotic formulation will show a significant reduction in daily crying duration compared to participants receiving the placebo.
Read the detailed description
Participants diagnosed with symptoms of infantile colic will be recruited to participate in this randomized, double-blind, placebo-controlled, two-arm parallel study. Eligible participants will be enrolled in this study for 6 weeks, and will undergo a 1-week run-in baseline period followed by a 4-week interventional period, then a 1-week follow-up period.
The study will consist of 7 visits (V0 to V6): 4 in-person visits that alternate with 3 phone calls.
- Conditions
- Colic
- Being tested
- Probiotic Formulation, Placebo
- Keywords
- Infantile colic, Crying time, Probiotics, Sleep duration
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic FormulationDietary supplement
Participants will be asked to take one sachet daily, containing 1 billion CFU of the probiotic formula. Sachets must be dissolved in warm water or mother's milk before consumption.
PlaceboDietary supplement
Participants will be asked to take one sachet containing the placebo daily. Sachets must be dissolved in warm water or mother's milk before consumption.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants in this group will be randomized to receive the probiotic formulation for 4 weeks. Receives: Dietary Supplement: Probiotic Formulation |
| Control Group | Placebo comparator | Participants in this group will be randomized to receive the placebo for 4 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of infantile colic
Comparison of the difference in the proportion of infants with reductions in mean daily crying duration by over 50 percent from baseline between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Measured: 5 weeks
Secondary outcomes (9)
Symptoms of infantile colic: Daily crying duration
Comparison of the average change from baseline in the mean daily crying duration between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Measured: 5 weeks
Symptoms of infantile colic: Number of crying episodes
Comparison of the change in the number of crying episodes from baseline between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Measured: 5 weeks
Symptoms of infantile colic: Sleep duration
Comparison of the difference in sleep duration from baseline between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Measured: 5 weeks
Symptoms of infantile colic: Time to a 25 and 50 percent reduction in cry/fuss time
Comparison of the difference in time to reach a 25 percent and 50 percent improvement in cry/fuss time from baseline between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Measured: 5 weeks
Symptoms of infantile colic: Parental perception
Comparison of the difference in the perceived evolution of colic symptoms by parents of participants in the probiotic and placebo groups, as assessed by questions about the evolution of colic symptoms at visits 2 and 4.
Measured: 5 weeks
Change in the mother's quality of life
Comparison of the changes in the overall score of the SF-36 from baseline (0 to 100; a higher score corresponds to a better quality of life), between mothers of participants in the probiotic and placebo groups.
Measured: 5 weeks
Bowel movement frequency
Comparison of the changes in bowel movement frequency and consistency from baseline between the probiotic and placebo groups, as assessed by the Amsterdam Infant Stool Scale.
Measured: 5 weeks
Fecal strain recovery of the probiotic
Presence of the probiotic strain in participants in the probiotic group, as determined by qPCR analysis of stool samples collected at baseline and at week 4.
Measured: 5 weeks
Fecal microbiome composition
Comparison of the differences in the composition of fecal microbiota and mycobiota between the probiotic and placebo groups, as determined by 16S sequencing of stool samples collected at baseline and at week 4.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start8 Feb 2022
- Primary completionSep 2023 (estimated)
- Study completionFeb 2024 (estimated)
Why it stopped: Null recruitment
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.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lallemand Health Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ProbiSearch SL
- Responsible party
- Sponsor
- Investigators
- Esther Jiménez Quintana, Ph.D., Study director, ProbiSearch SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198700
- Sponsor's protocol ID
- L-022
- Acronym
- PROCOLIN
- Status last verified
- Feb 2023
- First submitted
- 3 Dec 2021
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After publications of the results, de-identified data will be shared with qualified researchers and scientists upon reasonable request to the sponsor including a detailed proposal of the intended use of the data, as per the Lallemand Health Solutions Inc. Policy on Clinical Trial Transparency and Data Sharing (available upon request).
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Probiotic on Symptoms of Infantile Colic: a Randomized, Double-blind, Placebo-controlled Study (PROCOLIN)
- ClinicalTrials.gov ID
- NCT05198700
- Acronym / sponsor ID
- PROCOLIN / L-022
- Conditions
- Colic
- Keywords
- Infantile colic, Crying time, Probiotics, Sleep duration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Null recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lallemand Health SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- ProbiSearch SL
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 20 Jan 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.
The aim of this study is to evaluate the effects of a probiotic formulation on the daily crying patterns of infants. It is hypothesized that participants given the probiotic formulation will show a significant reduction in daily crying duration compared to participants receiving the placebo.
Detailed description
Participants diagnosed with symptoms of infantile colic will be recruited to participate in this randomized, double-blind, placebo-controlled, two-arm parallel study. Eligible participants will be enrolled in this study for 6 weeks, and will undergo a 1-week run-in baseline period followed by a 4-week interventional period, then a 1-week follow-up period.
The study will consist of 7 visits (V0 to V6): 4 in-person visits that alternate with 3 phone calls.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Dietary Supplement: Probiotic FormulationParticipants in this group will be randomized to receive the probiotic formulation for 4 weeks. |
| Control Group | Placebo comparator | Dietary Supplement: PlaceboParticipants in this group will be randomized to receive the placebo for 4 weeks. |
Who may qualify
- Ages
- Up to 8 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy male or female.
- Age ≤ 8 weeks old.
- Diagnosis of infantile colic according to the Rome IV criteria. Infants must show cry or fuss behaviour for 3 or more hours per day, during 3 or more days in 7 days.
- Exclusively breastfeeding and planning to breastfeed for duration of study.
- With a written informed consent signed by the father, mother, or legal guardian, and with expressed or implied consent of the other parent.
Key exclusion criteria (16 listed)
- Birthweight < 2500 g.
- Gestational age < 37 weeks.
- Apgar score at 5 minutes < 7.
- Partially or fully formula fed infants, with the exception of the first 4 days after birth.
- Stunted growth/weight loss (< 100 g/week from birth to last reported).
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 |
|---|---|---|
| Probiotic FormulationParticipants will be asked to take one sachet daily, containing 1 billion CFU of the probiotic formula. Sachets must be dissolved in warm water or mother's milk before consumption. | Dietary supplement | Experimental Group |
| PlaceboParticipants will be asked to take one sachet containing the placebo daily. Sachets must be dissolved in warm water or mother's milk before consumption. | Dietary supplement | Control Group |
Primary outcome
Symptoms of infantile colic
Time frame: 5 weeks
Comparison of the difference in the proportion of infants with reductions in mean daily crying duration by over 50 percent from baseline between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
9 secondary outcomes
Symptoms of infantile colic: Daily crying duration
Time frame: 5 weeks
Symptoms of infantile colic: Number of crying episodes
Time frame: 5 weeks
Symptoms of infantile colic: Sleep duration
Time frame: 5 weeks
Symptoms of infantile colic: Time to a 25 and 50 percent reduction in cry/fuss time
Time frame: 5 weeks
Symptoms of infantile colic: Parental perception
Time frame: 5 weeks
Change in the mother's quality of life
Time frame: 5 weeks
Bowel movement frequency
Time frame: 5 weeks
Fecal strain recovery of the probiotic
Time frame: 5 weeks
Fecal microbiome composition
Time frame: 5 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No. After publications of the results, de-identified data will be shared with qualified researchers and scientists upon reasonable request to the sponsor including a detailed proposal of the intended use of the data, as per the Lallemand Health Solutions Inc. Policy on Clinical Trial Transparency and Data Sharing (available upon request).
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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.
Esther Jiménez Quintana, Ph.D. study director
ProbiSearch SL
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic Formulation in people with Colic, run by Lallemand Health Solutions at 5 sites in Spain.
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 6 inclusion and 16 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: withdrawn, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Symptoms of infantile colic (time frame: 5 weeks). 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 3 Jul 2023.