Infantile ColicNCT04262648
Randomized Placebo-controlled Study of L. Reuteri NCIMB 30351 in GI Functional Disorders and Food Allergy in Newborns
A study testing Lactobacillus Reuteri in people with Infantile Colic and Constipation, run by NovoNatum Ltd at 2 sites in Russia.
Trial summary
This study is a randomized, placebo-controlled, single-masked (blinded), post-marketing clinical study of a drug Lactobacillus Reuteri NCIMB 30351 drops in functional disorders of gastrointestinal tract and skin symptoms of food allergies in children between the ages of one and four months inclusive. Read more about this study
- Who is it for?
- Ages 1 month to 5 months
- Conditions the study is for
- Infantile Colic, Constipation, Infantile Diarrhea
- What is being tested?
- Lactobacillus Reuteri
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesRussia
- Study dates
- 3 Mar 2020to 16 May 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 1 month to 5 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents / guardians speak Russian, understand the essence of study, are informed about the purpose of the study, understand their rights and signed informed consent form (ICF).
- Vaginal delivery.
- Full-term newborn.
- Age at the time of the signing of informed consent form 1-4 months 28 days.
- Breast- and formula-fed infants.
- Colic , constipation , diarrhea, regurgitation (single symptom or combination of several symptoms).
- Infant does not have other deviations in health, which would require the appointment of a specialized diet
- Parents / guardians can and ready to regularly fill out the proposed diary form.
Who cannot join
- Born by Cesarean section.
- Premature newborn.
- Congenital abnormalities or other clinical manifestations that may interfere with the study.
- Lactase food supplements.
- Other probiotic drugs, antibiotics, enteric antiseptics, antifungal and antiprotozoal drugs.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Children's City Clinical Hospital named after Bashlyaeva, Healthcare department of Moscow city
Moscow
Medical Center "St. Andrew's Hospitals - NEBOLIT"
Moscow
About this study
Official title: Randomized, Blinded, Placebo-controlled, Study of Clinical and Laboratory Effects of L. Reuteri NCIMB 30351 in Functional Disorders of Gastrointestinal Tract and Skin Symptoms of Food Allergy in Children During the First Months of Life
This study is a randomized, placebo-controlled, single-masked (blinded), post-marketing clinical study of a drug Lactobacillus Reuteri NCIMB 30351 drops in functional disorders of gastrointestinal tract and skin symptoms of food allergies in children between the ages of one and four months inclusive.
The aim of the study is to assess clinical effects of probiotics Lactobacillus Reuteri NCIMB 30351 drops on the symptoms of infantile colic, constipation, diarrhea, gastroesophageal reflux, atopic dermatitis/eczema in full-term newborns during the first months of life, laboratory parameters of microbiome will also be assessed.
Read more
A prospective study comparing two treatment groups:
Group 1 (treatment group) - 60 infants. Group 2 (control group) - 30 infants, placebo. The study drug will be taken in 1 time per day within 25 days. Allowed symptomatic therapy includes defoamers (simethicone-based preparations), carminative preparations (dill water (fennel)), etc.
- Being tested
- Lactobacillus Reuteri, Placebo
- Medical subject headings
- Colic, Constipation, Diarrhea, Infantile, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus ReuteriDietary supplement
Also called BioAmicus Lactobacillus drops
Lactobacillus Reuteri NCIMB 30351
PlaceboDietary supplement
Sunflower oil
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Dietary Supplement: Lactobacillus Reuteri |
| Control | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of infantile colics
Infantile colics are defined according to IV Rome criteria
Measured: 25 days from the start of treatment
Secondary outcomes (7)
Change in the number of constipations
Constipation is defined according to IV Rome criteria
Measured: 25 days from the start of treatment
Change in the number of diarrhea cases
Diarrhea is defined according to IV Rome criteria
Measured: 25 days from the start of treatment
Change in the number of gastroesophageal reflux (posseting) cases
Gastroesophageal reflux is defined according to IV Rome criteria
Measured: 25 days from the start of treatment
Presence of skin symptoms of food allergy
Presence or absence of skin symptoms of food allergy will be assessed by investigator during general skin examination
Measured: 25 days from the start of treatment
Change in 16S RNA sequencing
16S RNA in stool
Measured: 25 days from the start of treatment
Change in concentrations of stool carbohydrates
Carbohydrates concentrations will be measured in stool filtrate
Measured: 25 days from the start of treatment
Change in concentrations in stool filtrate of volatile fatty acids
Following volatile fatty acids concentrations will be assessed: acetic, propionic, butyric, valeric, caproic and their isomers
Measured: 25 days from the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start3 Mar 2020
- Primary completion16 May 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoNatum Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oleg Tyrsin, Study director, NovoNatum CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262648
- Sponsor's protocol ID
- BioAmicus-001
- Status last verified
- May 2023
- First submitted
- 7 Feb 2020
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tyrsin OY, Tyrsin DY, Nemenov DG, Ruzov AS, Odintsova VE, Koshechkin SI, D Amico L. Effect of Lactobacillus reuteri NCIMB 30351 drops on symptoms of infantile functional gastrointestinal disorders and gut microbiota in early infants: Results from a randomized, placebo-controlled clinical trial. Eur J Pediatr. 2024 May;183(5):2311-2324. doi: 10.1007/s00431-024-05473-y. Epub 2024 Mar 1.
PubMed 38427038
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Blinded, Placebo-controlled, Study of Clinical and Laboratory Effects of L. Reuteri NCIMB 30351 in Functional Disorders of Gastrointestinal Tract and Skin Symptoms of Food Allergy in Children During the First Months of Life
- ClinicalTrials.gov ID
- NCT04262648
- Acronym / sponsor ID
- BioAmicus-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- NovoNatum LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 10 Feb 2020 (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.
This study is a randomized, placebo-controlled, single-masked (blinded), post-marketing clinical study of a drug Lactobacillus Reuteri NCIMB 30351 drops in functional disorders of gastrointestinal tract and skin symptoms of food allergies in children between the ages of one and four months inclusive.
The aim of the study is to assess clinical effects of probiotics Lactobacillus Reuteri NCIMB 30351 drops on the symptoms of infantile colic, constipation, diarrhea, gastroesophageal reflux, atopic dermatitis/eczema in full-term newborns during the first months of life, laboratory parameters of microbiome will also be assessed.
A prospective study comparing two treatment groups:
Group 1 (treatment group) - 60 infants. Group 2 (control group) - 30 infants, placebo. The study drug will be taken in 1 time per day within 25 days. Allowed symptomatic therapy includes defoamers (simethicone-based preparations), carminative preparations (dill water (fennel)), etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: Lactobacillus Reuteri |
| Control | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 1 month to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Parents / guardians speak Russian, understand the essence of study, are informed about the purpose of the study, understand their rights and signed informed consent form (ICF).
- Vaginal delivery.
- Full-term newborn.
- Age at the time of the signing of informed consent form 1-4 months 28 days.
- Breast- and formula-fed infants.
Key exclusion criteria (5 listed)
- Born by Cesarean section.
- Premature newborn.
- Congenital abnormalities or other clinical manifestations that may interfere with the study.
- Lactase food supplements.
- Other probiotic drugs, antibiotics, enteric antiseptics, antifungal and antiprotozoal drugs.
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 |
|---|---|---|
| Lactobacillus ReuteriAlso: BioAmicus Lactobacillus dropsLactobacillus Reuteri NCIMB 30351 | Dietary supplement | Treatment |
| PlaceboSunflower oil | Dietary supplement | Control |
Primary outcome
Change in the number of infantile colics
Time frame: 25 days from the start of treatment
Infantile colics are defined according to IV Rome criteria
7 secondary outcomes
Change in the number of constipations
Time frame: 25 days from the start of treatment
Change in the number of diarrhea cases
Time frame: 25 days from the start of treatment
Change in the number of gastroesophageal reflux (posseting) cases
Time frame: 25 days from the start of treatment
Presence of skin symptoms of food allergy
Time frame: 25 days from the start of treatment
Change in 16S RNA sequencing
Time frame: 25 days from the start of treatment
Change in concentrations of stool carbohydrates
Time frame: 25 days from the start of treatment
Change in concentrations in stool filtrate of volatile fatty acids
Time frame: 25 days from the start of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Derived from this study: PubMed 38427038Tyrsin OY, Tyrsin DY, Nemenov DG, Ruzov AS, Odintsova VE, Koshechkin SI, D Amico L. Effect of Lactobacillus reuteri NCIMB 30351 drops on symptoms of infantile functional gastrointestinal disorders and gut microbiota in early infants: Results from a randomized, placebo-controlled clinical trial. Eur J Pediatr. 2024 May;183(5):2311-2324. doi: 10.1007/s00431-024-05473-y. Epub 2024 Mar 1.
- Individual participant dataSharing planned: Undecided
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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.
Oleg Tyrsin study director
NovoNatum CEO
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus Reuteri in people with Infantile Colic and Constipation, run by NovoNatum Ltd at 2 sites in Russia.
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 8 inclusion and 5 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 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 the number of infantile colics (time frame: 25 days from the start 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 NCT04262648, 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 12 May 2023.