ColicPhase 2NCT05685030
Probiotics Strains for Infant Colic
A Phase 2 study testing Limosilactobacillus reuteri CCT 7862 and Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863 in people with Colic, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude at 1 site in Brazil.
Trial summary
Interest in the use of probiotics as a potential treatment to reduce crying in babies with colic has increased lately. Recent studies have reported that the gut microbiota in infants with colic is characterized by lower proportions of Lactobacilli and Bifidobacteria and higher proportions of opportunistic… Read more about this study
- Who is it for?
- Ages 17 to 23 daysHealthy volunteers can take part
- Conditions the study is for
- Colic
- What is being tested?
- Limosilactobacillus reuteri CCT 7862 and Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Jan 2023to 30 Jul 2023
- 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 17 to 23 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 20 days ± 3 days.
- Informed consent form signed by parents
- Both gender
- Availability to complete scales daily and answer phone calls and/or text messages.
Who cannot join
- Birth weight <2500 g;
- current intake of antibiotics, prebiotics, or probiotics by the baby or mother;
- Children with known moderate or severe disease of any system (neural, skeletal, muscular, cutaneous, gastrointestinal, respiratory, genital, urinary, immune),
- parental difficulty in understanding study requirements as judged by physician.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Monique Michels
Criciúma, Santa Catarina, 88806000
monique michels, PhD, +5548996274651, monique@biohall.com.br
About this study
Official title: Evaluation of the Effectiveness of Probiotic Strains (L. Reuteri CCT 7862) and (B. Lactis CCT 7858 + L. Rhamnosus - CCT 7863) in Reducing Colic and Improving Gastrointestinal Health in Newborn
Interest in the use of probiotics as a potential treatment to reduce crying in babies with colic has increased lately. Recent studies have reported that the gut microbiota in infants with colic is characterized by lower proportions of Lactobacilli and Bifidobacteria and higher proportions of opportunistic proteobacteria (such as Escherichia coli, Enterobacter aerogenes and Klebsiella spp.) in comparison with the control babies.
Therefore, based on data in the literature, it is understood that there is evidence of the effectiveness of using probiotics, either alone or in the form of a blend, to alleviate the symptoms of infantile colic.
Read the detailed description
Infantile colic represents a self-limiting temporary condition, which occurs in about one in five babies in the first few months of life, and is characterized by inconsolable crying and fussiness of unknown cause. Despite its benign nature, infantile colic serves as a significant source of maternal anxiety and depression, impaired family functioning, and the most common reason for seeking medical advice in this age group. Infant colic is also associated with sleep problems in babies.
Parents and caregivers often seek medical attention for colic, including the use of medication, plant fiber, lactase, sucrose solution, hypoallergenic diet, and herbal tea. However, there is no single effective and safe intervention for infantile colic.
Interest in the use of probiotics as a potential treatment to reduce crying in babies with colic has increased lately. Recent studies have reported that the gut microbiota in infants with colic is characterized by lower proportions of Lactobacilli and Bifidobacteria and higher proportions of opportunistic proteobacteria (such as Escherichia coli, Enterobacter aerogenes and Klebsiella spp.) in comparison with the control babies. Thus, several researchers have suggested that probiotics may be useful in treating breastfed babies with colic and reducing crying time.
One study showed that administration of Lactobacillus reuteri DSM 17938 improved colic symptoms, although the effectiveness was only seen in breastfed and not formula fed infants. Another study showed that treatment with a combination of L. casei, L. rhamnosus, Streptococcus thermophilus, B. breve, L. acidophilus, B. infantiles, L. bulgaricus and fructooligosaccharides (FOS) reduced the duration of crying by almost 35 min compared to placebo. Furthermore, other authors has reported a reduced incidence of caregiver-reported colic when infants were supplemented with a combination of B. animalis subsp. lactis BB-12 and an unidentified strain of S. thermophilus, although colic was not formally diagnosed by a physician, which reduced the strength of the studies. A recent study on the same BB-12 strain overcame this deficiency by formally diagnosing colic using Rome-III criteria. However, this study showed that the response rate did not significantly improve over placebo until day 21. On the other hand, one study reported that the use of L. rhamnosus GG (ATCC53103) had no significant effect on crying in babies with colic. In another study, no significant differences were found in crying and irritability between the probiotic and placebo groups when supplemented with L. reuteri ATCC55730 or B. lactis BB-12.
- Conditions
- Colic
- Being tested
- Placebo, Limosilactobacillus reuteri CCT 7862, Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863
- Keywords
- infant colic, probiotic
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
product vehicle (sunflower oil)
Limosilactobacillus reuteri CCT 7862Dietary supplement
Limosilactobacillus reuteri CCT 7862 - 1 x 10e9 UFC/ day.
Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863Dietary supplement
Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863 - 1 x 10e9 UFC/ day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | product vehicle (sunflower oil) Receives: Dietary Supplement: Placebo |
| Limosilactobacillus reuteri CCT 7862 | Experimental | Limosilactobacillus reuteri CCT 7862 - 1 x 10e9 UFC/ daY. Receives: Dietary Supplement: Limosilactobacillus reuteri CCT 7862 |
| Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863 | Experimental | Blend: Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863 - 1 x 10e9 UFC/ day. Receives: Dietary Supplement: Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of probiotics strains by total daily crying time
Efficacy of probiotics strains by total daily crying time (minutes for day) recorded by parents daily
Measured: Change from baseline at three months
Efficacy of probiotics strains by total daily agitation time
Efficacy of probiotics strains by total daily agitation time (minutes for day) recorded by parents daily
Measured: Change from baseline at three months
Secondary outcomes (2)
Safety and Efficacy of probiotics strains
Safety and Efficacy of probiotics strains by baby sleep duration (minutes for day) and and sleep quality through scale recorded by parents daily. This Score use a four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "some- times," 2 = "often," and 3 = "almost always").
Measured: Change from baseline at three months
Safety and Efficacy of probiotics strains
Safety and Efficacy of probiotics strains by daily frequency evacuation and stool consistency (Bristol scale). There are seven types of stools (faeces) according to the Bristol Stool Chart. Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhoea and urgency.
Measured: Change from baseline at three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start5 Jan 2023
- Primary completion5 Jan 2023
- Study completion30 Jul 2023 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase II randomized, placebo-controlled, triple-blind clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monique Michels, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685030
- Sponsor's protocol ID
- 63543922.2.0000.0119
- Status last verified
- Jan 2023
- First submitted
- 12 Dec 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Probiotic Strains (L. Reuteri CCT 7862) and (B. Lactis CCT 7858 + L. Rhamnosus - CCT 7863) in Reducing Colic and Improving Gastrointestinal Health in Newborn
- ClinicalTrials.gov ID
- NCT05685030
- Acronym / sponsor ID
- 63543922.2.0000.0119
- Conditions
- Colic
- Keywords
- infant colic, probiotic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da SaudeUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 13 Jan 2023 (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.
Interest in the use of probiotics as a potential treatment to reduce crying in babies with colic has increased lately. Recent studies have reported that the gut microbiota in infants with colic is characterized by lower proportions of Lactobacilli and Bifidobacteria and higher proportions of opportunistic proteobacteria (such as Escherichia coli, Enterobacter aerogenes and Klebsiella spp.) in comparison with the control babies.
Therefore, based on data in the literature, it is understood that there is evidence of the effectiveness of using probiotics, either alone or in the form of a blend, to alleviate the symptoms of infantile colic.
Detailed description
Infantile colic represents a self-limiting temporary condition, which occurs in about one in five babies in the first few months of life, and is characterized by inconsolable crying and fussiness of unknown cause. Despite its benign nature, infantile colic serves as a significant source of maternal anxiety and depression, impaired family functioning, and the most common reason for seeking medical advice in this age group. Infant colic is also associated with sleep problems in babies.
Parents and caregivers often seek medical attention for colic, including the use of medication, plant fiber, lactase, sucrose solution, hypoallergenic diet, and herbal tea. However, there is no single effective and safe intervention for infantile colic.
Interest in the use of probiotics as a potential treatment to reduce crying in babies with colic has increased lately. Recent studies have reported that the gut microbiota in infants with colic is characterized by lower proportions of Lactobacilli and Bifidobacteria and higher proportions of opportunistic proteobacteria (such as Escherichia coli, Enterobacter aerogenes and Klebsiella spp.) in comparison with the control babies. Thus, several researchers have suggested that probiotics may be useful in treating breastfed babies with colic and reducing crying time.
One study showed that administration of Lactobacillus reuteri DSM 17938 improved colic symptoms, although the effectiveness was only seen in breastfed and not formula fed infants. Another study showed that treatment with a combination of L. casei, L. rhamnosus, Streptococcus thermophilus, B. breve, L. acidophilus, B. infantiles, L. bulgaricus and fructooligosaccharides (FOS) reduced the duration of crying by almost 35 min compared to placebo. Furthermore, other authors has reported a reduced incidence of caregiver-reported colic when infants were supplemented with a combination of B. animalis subsp. lactis BB-12 and an unidentified strain of S. thermophilus, although colic was not formally diagnosed by a physician, which reduced the strength of the studies. A recent study on the same BB-12 strain overcame this deficiency by formally diagnosing colic using Rome-III criteria. However, this study showed that the response rate did not significantly improve over placebo until day 21. On the other hand, one study reported that the use of L. rhamnosus GG (ATCC53103) had no significant effect on crying in babies with colic. In another study, no significant differences were found in crying and irritability between the probiotic and placebo groups when supplemented with L. reuteri ATCC55730 or B. lactis BB-12.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Phase II randomized, placebo-controlled, triple-blind clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboproduct vehicle (sunflower oil) |
| Limosilactobacillus reuteri CCT 7862 | Experimental | Dietary Supplement: Limosilactobacillus reuteri CCT 7862Limosilactobacillus reuteri CCT 7862 - 1 x 10e9 UFC/ daY. |
| Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863 | Experimental | Dietary Supplement: Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863Blend: Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863 - 1 x 10e9 UFC/ day. |
Who may qualify
- Ages
- 17 to 23 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 20 days ± 3 days.
- Informed consent form signed by parents
- Both gender
- Availability to complete scales daily and answer phone calls and/or text messages.
Key exclusion criteria (4 listed)
- Birth weight <2500 g;
- current intake of antibiotics, prebiotics, or probiotics by the baby or mother;
- Children with known moderate or severe disease of any system (neural, skeletal, muscular, cutaneous, gastrointestinal, respiratory, genital, urinary, immune),
- parental difficulty in understanding study requirements as judged by physician.
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 |
|---|---|---|
| Placeboproduct vehicle (sunflower oil) | Dietary supplement | Placebo |
| Limosilactobacillus reuteri CCT 7862Limosilactobacillus reuteri CCT 7862 - 1 x 10e9 UFC/ day. | Dietary supplement | Limosilactobacillus reuteri CCT 7862 |
| Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863 - 1 x 10e9 UFC/ day | Dietary supplement | Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863 |
Primary outcome
Efficacy of probiotics strains by total daily crying time
Time frame: Change from baseline at three months
Efficacy of probiotics strains by total daily crying time (minutes for day) recorded by parents daily
Efficacy of probiotics strains by total daily agitation time
Time frame: Change from baseline at three months
Efficacy of probiotics strains by total daily agitation time (minutes for day) recorded by parents daily
2 secondary outcomes
Safety and Efficacy of probiotics strains
Time frame: Change from baseline at three months
Safety and Efficacy of probiotics strains
Time frame: Change from baseline at three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Limosilactobacillus reuteri CCT 7862 and Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863 in people with Colic, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude at 1 site in Brazil.
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 4 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: status not confirmed, as of the sponsor's last update on 13 Jan 2023. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of probiotics strains by total daily crying time (time frame: Change from baseline at three months). The study lists 2 primary outcomes in all. 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 13 Jan 2023.