Infantile ColicCOLICNCT05129384
The COLIC Study: Colonization of the Infant Gut With B. Infantis EVC001 to Reduce Symptoms of Colic
A study of Infantile Colic, run by Evolve BioSystems, Inc. at 1 site in United States.
Trial summary
To investigate whether B. infantis EVC001 colonization in the infant gut can reduce symptoms of colic Read more about this study
- Who is it for?
- Ages 14 to 42 daysHealthy volunteers can take part
- Conditions the study is for
- Infantile Colic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2022to 1 Jun 2022
- 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 14 to 42 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants with a diagnosis of infantile colic per Rome IV criteria and reported to cry/fuss for ≥ 3 hours/day, within a 24-hour period as determined by the 24-hour cry/fuss eDiary AND 24 hours of LENA vocalizations
- Infants with a gestational period of ≥ 37 to 42 weeks
- Infants between 14 and ≤ 42 days of life at the completion of screening/baseline tasks
- Infants exclusively breastfed for at least 7 days immediately prior to enrollment and with mother's intent to continue feeding breast milk exclusively for the duration of the study
- Mothers willing to use their own electronic device(s) to download and utilize all required study software (decentralized trial platform on a mobile device and the LENA device software on a Windows 10 or higher laptop or desktop that has at least 10 GB of free space and fast, reliable internet)
- Mother is fluent in English
Who cannot join
- Infants born in multiple birth (i.e., twins, triplets, etc.)
- Infants born with medical complications (i.e., neurological, cerebral palsy, confirmed food allergies)
- Infants with current evidence of failure to thrive, fever, or illness
- Infants with any GI tract abnormalities
- Antibiotic, infant formula, solid food or iron supplement intake within 7 days prior to enrollment or mother's intent to feed non-study probiotics, prebiotics, infant formula, solid food or iron supplements to their infant at any time during the study
- Infants who have consumed any probiotics since birth
Show all 11Show fewer
- Unwillingness to discontinue/avoid products used to treat IC (i.e., Simethicone, gripe water, colic drops, etc.) during the study. Note: consumption of IC products prior to the baseline period is NOT exclusionary
- Maternal use of probiotics containing B. infantis during pregnancy, after the baby's birth and/or intent to use probiotics containing B. infantis at any time throughout the study
- Maternal smoking or smoking within the home by any household member currently or during pregnancy
- Mother following exclusionary diet due to her infant's colic (i.e., dairy elimination diet)
- Any infant the Investigator deems to be ineligible for participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Colonization of the Infant Gut With B. Infantis EVC001 to Reduce Symptoms of Colic
To investigate whether B. infantis EVC001 colonization in the infant gut can reduce symptoms of colic
Read the detailed description
There is evidence to support that B. infantis EVC001 supplementation may ameliorate symptoms associated with colic by establishing and maintaining the necessary gut microbial composition to promote proper barrier and immune function in infants. The primary objective of this study is to assess the effect of the probiotic, B. infantis EVC001, on reducing the duration of crying/fussing symptoms of breastfed infants diagnosed with infantile colic from Baseline to Day 14.
- Conditions
- Infantile Colic
- Being tested
- B. infantis EVC001 or Lactose Placebo
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B. infantis EVC001 or Lactose PlaceboDietary supplement
Also called Lactose Placebo
Infant probiotic
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | B. infantis EVC001 infant probiotic Receives: Dietary Supplement: B. infantis EVC001 or Lactose Placebo |
| Placebo | Placebo comparator | Lactose Receives: Dietary Supplement: B. infantis EVC001 or Lactose Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in crying/fussing duration
Assess the effect of the probiotic, B. infantis EVC001, on duration of crying/fussing symptoms of breastfed infants diagnosed with infantile colic
Measured: Baseline to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start23 Feb 2022
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Why it stopped: Company pursuing other research paths
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Infants will be randomized 1:1 to one of two study arms (treatment or placebo)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evolve BioSystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robin Flannery, Study director, Evolve BioSystemsParth Shah, Principal investigator, Obvio Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129384
- Sponsor's protocol ID
- EV-9101
- Acronym
- COLIC
- Status last verified
- Jun 2022
- First submitted
- 10 Nov 2021
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our intent is to share group/averaged data for the cohorts to decrease risks associated with patient anonymity
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonization of the Infant Gut With B. Infantis EVC001 to Reduce Symptoms of Colic
- ClinicalTrials.gov ID
- NCT05129384
- Acronym / sponsor ID
- COLIC / EV-9101
- Conditions
- Infantile Colic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company pursuing other research paths
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Evolve BioSystems, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 22 Nov 2021 (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.
To investigate whether B. infantis EVC001 colonization in the infant gut can reduce symptoms of colic
Detailed description
There is evidence to support that B. infantis EVC001 supplementation may ameliorate symptoms associated with colic by establishing and maintaining the necessary gut microbial composition to promote proper barrier and immune function in infants. The primary objective of this study is to assess the effect of the probiotic, B. infantis EVC001, on reducing the duration of crying/fussing symptoms of breastfed infants diagnosed with infantile colic from Baseline to Day 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Infants will be randomized 1:1 to one of two study arms (treatment or placebo)
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Dietary Supplement: B. infantis EVC001 or Lactose PlaceboB. infantis EVC001 infant probiotic |
| Placebo | Placebo comparator | Dietary Supplement: B. infantis EVC001 or Lactose PlaceboLactose |
Who may qualify
- Ages
- 14 to 42 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Infants with a diagnosis of infantile colic per Rome IV criteria and reported to cry/fuss for ≥ 3 hours/day, within a 24-hour period as determined by the 24-hour cry/fuss eDiary AND 24 hours of LENA vocalizations
- Infants with a gestational period of ≥ 37 to 42 weeks
- Infants between 14 and ≤ 42 days of life at the completion of screening/baseline tasks
- Infants exclusively breastfed for at least 7 days immediately prior to enrollment and with mother's intent to continue feeding breast milk exclusively for the duration of the study
- Mothers willing to use their own electronic device(s) to download and utilize all required study software (decentralized trial platform on a mobile device and the LENA device software on a Windows 10 or higher laptop or desktop that has at least 10 GB of free space and fast, reliable internet)
Key exclusion criteria (11 listed)
- Infants born in multiple birth (i.e., twins, triplets, etc.)
- Infants born with medical complications (i.e., neurological, cerebral palsy, confirmed food allergies)
- Infants with current evidence of failure to thrive, fever, or illness
- Infants with any GI tract abnormalities
- Antibiotic, infant formula, solid food or iron supplement intake within 7 days prior to enrollment or mother's intent to feed non-study probiotics, prebiotics, infant formula, solid food or iron supplements to their infant at any time during the study
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 |
|---|---|---|
| B. infantis EVC001 or Lactose PlaceboAlso: Lactose PlaceboInfant probiotic | Dietary supplement | Placebo, Treatment |
Primary outcome
Change in crying/fussing duration
Time frame: Baseline to Day 14
Assess the effect of the probiotic, B. infantis EVC001, on duration of crying/fussing symptoms of breastfed infants diagnosed with infantile colic
Results and safety
The study was stopped early (reason given: Company pursuing other research paths). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Individual participant dataSharing planned: No. Our intent is to share group/averaged data for the cohorts to decrease risks associated with patient anonymity
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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.
Robin Flannery study director
Evolve BioSystems
Parth Shah principal investigator
Obvio Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Infantile Colic, run by Evolve BioSystems, Inc. at 1 site in United States.
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 11 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 29 Aug 2022. 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 United States. 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: Company pursuing other research paths). 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?
Change in crying/fussing duration (time frame: Baseline to Day 14). 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 29 Aug 2022.