Infantile ColicNCT04374955
The Effect of Probiotic Added to Maternal Diet on Infantile Colic and Intestinal Microbiota Content
A study testing Activia Probiotics Shot and Routine care in people with Infantile Colic and Microbial Colonization, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effect of probiotic added to the diet of mothers on infantile colic in the postpartum period and the content of the neonatal intestinal microbiota. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infantile Colic, Microbial Colonization, Crying
- What is being tested?
- Activia Probiotics Shot and Routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Oct 2020to 1 Jun 2021
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mother's ability to speak Turkish,
- Single pregnancy,
- Delivery time is between 37 <GH <42 weeks,
- The mother does not have a chronic disease,
- Vaginal birth,
- The mother's not using antibiotic drugs during pregnancy and postpartum period,
Show all 14Show fewer
- Neonatal diagnosis of infantile colic,
- Scoring 10 points below the Beck Depression Inventory,
- Smoking of the woman during pregnancy and postpartum period,
- The absence of Intrauterine Growth Retardation (IUGR) or genetic disease in the newborn,
- Birth weight is in the range of 2500-4000 gr.
- No gastrointestinal disease in the newborn,
- 50% of the newborn is feeding on breast milk,
- No more than 24 hours of Early Membrane Rupture (EMR) at birth.
Who cannot join
- Having problems with the breast in the mother,
- The mother is using probiotics / antibiotics before randomization and during her pregnancy,
- Mothers who are included in the study sample, take part in other clinical studies at the same time.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Eğitim ve Araştırma Hastanesi
Istanbul, Sultangazi, 34096
About this study
Official title: The Effect of Probiotic Added to Maternal Diet on Infantile Colic and Intestinal Microbiota Content: A Randomized Controlled Trials
This study aims to investigate the effect of probiotic added to the diet of mothers on infantile colic in the postpartum period and the content of the neonatal intestinal microbiota.
Read the detailed description
Infantile colic, by definition, is defined as excessive crying in the afternoon or evening, with no specific reason, starting at the first weeks of newborn life, lasting at least 3 weeks, longer than 3 hours a day and more than 3 days a week. Infantile colic is a common newborn problem worldwide, affecting approximately 20% of infants. Although infantile colic is considered a self-limiting and benign problem, it is a stressful problem for both newborns and parents.
It is thought that the factors affecting infantile colic etiology may be the mode of delivery, diet, birth weight, intestinal contractions, lactose intolerance, food hypersensitivity, gas, parental misinterpretation of the normal crying model, or various combinations of the above. In recent years and related evidence, it has been suggested that motility disorder and intestinal neuronal hyperexcitability are the most important pathogenic factor in infantile colic etiology. However, increasing evidence suggests that changes in the gut microbiota may contribute to the development of this condition. By definition, microbiota is expressed as a collection of microorganisms within a certain environment or ecosystem. While the microbiota formation forms pathogenic, commensal and symbiotic microorganisms found in the human body, the formation of the intestinal microbiota (colonization with bacteria) begins in the womb, with the transition from the vagina at birth, this colonization continues intensely and the foundations of the intestinal microbiota are laid in the first 3 months of life. The ideal situation for the microbiota is that the beneficial and harmful bacteria in the intestinal flora stay in balance and form a healthy flora. While discussing what is a healthy microbiota, it is expressed as dysbiosis in case of beneficial and harmful flora in balance.
In infantile colic, when the microbial structure was evaluated, it was seen to be characterized by different microbial patterns. In the first 2 weeks of life, infants with infantile colic have been reported to have a lower variety and stability of the gut microbiota. When we look at the studies about microbiota, it was seen that especially in colic babies, E. coli bacteria is found to be excessive, and the amount of bifidobacterium and lactobacilli are decreased. In this case, coliforms are reported to cause pain by creating excessive gas and inflammatory lipopolysaccharides as a result of intestinal fermentation. In addition, studies show that babies with colic differ from those without babies without microbiota, whereas babies with colic showed low microbiota diversity and stability in the first weeks of life, and no difference was observed in the 3 to 4 month evaluations. Another important factor that plays a role in infantile colic etiology is diet. Breast milk, which is the most important food source for the newborn, has a unique and complex microbiological composition, rich oligosaccharide content, immunological factors and a probiotic (in the form of Bifidobacterium and Lactobacillus) and prebiotics that have the ability to ensure the content and mucosal development of the intestinal microbiota if taken in sufficient quantity. human milk oligosaccharide (HMO)) combination. When the microbial changes of the babies who were breastfed and fed formula formula were compared, it was observed that the rate of bifidobacterium and microorganism content of the babies who were breastfed were 10 times richer than the formula formula. In a study by Grönlund et al., 35-36 of pregnancy among 67 mothers. When the stool samples and breast milk samples taken from the baby during the first week and in the 1st month were evaluated, it was found that the content of bifidobacterium (the most dense bifidobacterium longum) in the stool content and milk of the mother was the most important factor affecting the type and amount of bifidobacterium in the baby's stool. These changes suggest that a condition of intestinal dysbiosis may play a role in the expression of infantile colic symptoms by modulating various neural, endocrine, immune, and humoral signaling pathways.
Scientists are trying to develop formulas by studying the relationships between colic and microbiome. Accordingly, if changes in the intestinal microbiota really play a role in infantile colic pathogenesis, it is thought that manipulation of the intestinal microbiome may be a preventive measure and play a therapeutic role in the evolution of these diseases.
Considering that dysbiosis may play a role in infantile colic pathogenesis, there is interest in modulating the gut microbiota, including the use of probiotics for the management of infantile colic. In particular, it is a well-known probiotic that positively modifies the composition of the intestinal microbiota of the Bifidobacterium species and the function of the immune system.
Today, the effect of probiotics added to the diet of the mother and newborn nutrition on the prevention of colic and microbiota content has been evaluated. One study found that when probiotics were added to breast milk, it was effective in reducing the crying time in babies with colic. In studies on the role of probiotics on colic, Lactobacillus species have also been investigated for colic and microbiota, and have been found to reduce crying time in studies showing that they are effective in colic management. When the effects of probiotics given to infants with infantile colic on microbiota are examined, it has been observed in studies that the harmful bacteria types such as H.pylori, Klebsiella, E.coli decrease the amount of beneficial bacteria such as bifidobacterium and lactobacilli. However, studies generally include the addition of probiotics to the diet of babies with colic, and a lack of studies proving that the probiotics given to the mother or foods from natural probiotics (fermented products such as beer, bread, wine, kefir, kumis and cheese) in the mother's diet had a positive effect on the reduction of infantile colic.
This study was planned as a double-blind, randomized placebo-controlled trials in order to evaluate the effect of the probiotic added to the diet of the mothers on infantile colic and the contents of the neonatal intestinal microbiota in the postpartum period.
- Conditions
- Infantile Colic, Microbial Colonization, Crying
- Being tested
- Activia Probiotics Shot, Routine care
- Keywords
- infantile colic, colic, probiotics, maternal diet, microbiota
- Medical subject headings
- Colic, Communicable Diseases, Crying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activia Probiotics ShotDietary supplement
The product contains Actiregularis - at least 2x106 cfu / g.
Routine careOther
Routine care of the hospital will be provided.
| Study group | Role | What they receive |
|---|---|---|
| İnfantile colic | Experimental | Mothers of babies diagnosed with infantile colic in the intervention group will receive routine care and start taking probiotic products after the first stool of the babies and blood is taken for intestinal permeability and will continue for 15 days. Receives: Dietary Supplement: Activia Probiotics Shot; Other: Routine care |
| Control | Other | Mothers of babies diagnosed with infantile colic in the control group will receive routine care for 15 days after blood is taken for the first stool and intestinal permeability of the babies. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
crying times
reduction of ≥50% of mean daily crying duration. The mothers will provided with a diary(according to the Barr Baby Diary) and they will instructed on how to complete it daily with data concerning administration of daily dose of the study product, number and duration of crying episodes. In addition, mothers will be trained to use stopwatches. They will keep the crying times daily.
Measured: up to 28 days
microbiota analysis
stool sample.
Measured: up to 28 days
Secondary outcomes (5)
Mother's depression
Evaluation of mothers' depression states will be evaluated by filling the "Beck Depression Inventory".
Measured: up to 28 days
Binding
"Maternal Attachment Scale" will be filled in mothers to measure the attachment status between mother and baby.
Measured: up to 28 days
Babies' height (cm) anthropometric evaluation
Measured: up to 28 days
weight (kg) anthropometric evaluation
Measured: up to 28 days
head circumference (cm) anthropometric evaluation
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start7 Oct 2020
- Primary completion1 Apr 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One blind, Randomized controlled Trials
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Aysu Yıldız Karaahmet, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374955
- Sponsor's protocol ID
- a6pu2f37
- Status last verified
- Jun 2021
- First submitted
- 29 Apr 2020
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol can be shared with other researchers.
Publications
Yildiz Karaahmet A, Dolgun G, Ozen M, Oguz D. Effect of Maternal Probiotics on Infantile Colic Symptoms and Maternal Quality of Life and Maternal Attachment: A Single-Blind, Randomized Controlled Study. Altern Ther Health Med. 2025 Mar;31(2):18-22.
PubMed 39715568Karaahmet AY, Dolgun G, Ozen M. Effects of probiotics on gastrointestinal symptoms, anthropometric measurements, and breastfeeding duration in infants with colic: a randomized control trial. Sao Paulo Med J. 2024 Apr 22;142(4):e2023069. doi: 10.1590/1516-3180.2023.0069.R1.31052023. eCollection 2024.
PubMed 38655990Yildiz Karaahmet A, Dolgun G, Ozen M. Probiotics added to maternal nutrition affect infantile colic symptoms and fecal microbiota profile: a single-blind randomized controlled study. Clin Exp Pediatr. 2022 Nov;65(11):547-554. doi: 10.3345/cep.2022.00766. Epub 2022 Sep 23.
PubMed 36229024
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotic Added to Maternal Diet on Infantile Colic and Intestinal Microbiota Content: A Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT04374955
- Acronym / sponsor ID
- a6pu2f37
- Conditions
- Infantile Colic, Microbial Colonization, Crying
- Keywords
- infantile colic, colic, probiotics, maternal diet, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 5 May 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 aims to investigate the effect of probiotic added to the diet of mothers on infantile colic in the postpartum period and the content of the neonatal intestinal microbiota.
Detailed description
Infantile colic, by definition, is defined as excessive crying in the afternoon or evening, with no specific reason, starting at the first weeks of newborn life, lasting at least 3 weeks, longer than 3 hours a day and more than 3 days a week. Infantile colic is a common newborn problem worldwide, affecting approximately 20% of infants. Although infantile colic is considered a self-limiting and benign problem, it is a stressful problem for both newborns and parents.
It is thought that the factors affecting infantile colic etiology may be the mode of delivery, diet, birth weight, intestinal contractions, lactose intolerance, food hypersensitivity, gas, parental misinterpretation of the normal crying model, or various combinations of the above. In recent years and related evidence, it has been suggested that motility disorder and intestinal neuronal hyperexcitability are the most important pathogenic factor in infantile colic etiology. However, increasing evidence suggests that changes in the gut microbiota may contribute to the development of this condition. By definition, microbiota is expressed as a collection of microorganisms within a certain environment or ecosystem. While the microbiota formation forms pathogenic, commensal and symbiotic microorganisms found in the human body, the formation of the intestinal microbiota (colonization with bacteria) begins in the womb, with the transition from the vagina at birth, this colonization continues intensely and the foundations of the intestinal microbiota are laid in the first 3 months of life. The ideal situation for the microbiota is that the beneficial and harmful bacteria in the intestinal flora stay in balance and form a healthy flora. While discussing what is a healthy microbiota, it is expressed as dysbiosis in case of beneficial and harmful flora in balance.
In infantile colic, when the microbial structure was evaluated, it was seen to be characterized by different microbial patterns. In the first 2 weeks of life, infants with infantile colic have been reported to have a lower variety and stability of the gut microbiota. When we look at the studies about microbiota, it was seen that especially in colic babies, E. coli bacteria is found to be excessive, and the amount of bifidobacterium and lactobacilli are decreased. In this case, coliforms are reported to cause pain by creating excessive gas and inflammatory lipopolysaccharides as a result of intestinal fermentation. In addition, studies show that babies with colic differ from those without babies without microbiota, whereas babies with colic showed low microbiota diversity and stability in the first weeks of life, and no difference was observed in the 3 to 4 month evaluations. Another important factor that plays a role in infantile colic etiology is diet. Breast milk, which is the most important food source for the newborn, has a unique and complex microbiological composition, rich oligosaccharide content, immunological factors and a probiotic (in the form of Bifidobacterium and Lactobacillus) and prebiotics that have the ability to ensure the content and mucosal development of the intestinal microbiota if taken in sufficient quantity. human milk oligosaccharide (HMO)) combination. When the microbial changes of the babies who were breastfed and fed formula formula were compared, it was observed that the rate of bifidobacterium and microorganism content of the babies who were breastfed were 10 times richer than the formula formula. In a study by Grönlund et al., 35-36 of pregnancy among 67 mothers. When the stool samples and breast milk samples taken from the baby during the first week and in the 1st month were evaluated, it was found that the content of bifidobacterium (the most dense bifidobacterium longum) in the stool content and milk of the mother was the most important factor affecting the type and amount of bifidobacterium in the baby's stool. These changes suggest that a condition of intestinal dysbiosis may play a role in the expression of infantile colic symptoms by modulating various neural, endocrine, immune, and humoral signaling pathways.
Scientists are trying to develop formulas by studying the relationships between colic and microbiome. Accordingly, if changes in the intestinal microbiota really play a role in infantile colic pathogenesis, it is thought that manipulation of the intestinal microbiome may be a preventive measure and play a therapeutic role in the evolution of these diseases.
Considering that dysbiosis may play a role in infantile colic pathogenesis, there is interest in modulating the gut microbiota, including the use of probiotics for the management of infantile colic. In particular, it is a well-known probiotic that positively modifies the composition of the intestinal microbiota of the Bifidobacterium species and the function of the immune system.
Today, the effect of probiotics added to the diet of the mother and newborn nutrition on the prevention of colic and microbiota content has been evaluated. One study found that when probiotics were added to breast milk, it was effective in reducing the crying time in babies with colic. In studies on the role of probiotics on colic, Lactobacillus species have also been investigated for colic and microbiota, and have been found to reduce crying time in studies showing that they are effective in colic management. When the effects of probiotics given to infants with infantile colic on microbiota are examined, it has been observed in studies that the harmful bacteria types such as H.pylori, Klebsiella, E.coli decrease the amount of beneficial bacteria such as bifidobacterium and lactobacilli. However, studies generally include the addition of probiotics to the diet of babies with colic, and a lack of studies proving that the probiotics given to the mother or foods from natural probiotics (fermented products such as beer, bread, wine, kefir, kumis and cheese) in the mother's diet had a positive effect on the reduction of infantile colic.
This study was planned as a double-blind, randomized placebo-controlled trials in order to evaluate the effect of the probiotic added to the diet of the mothers on infantile colic and the contents of the neonatal intestinal microbiota in the postpartum period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- One blind, Randomized controlled Trials
| Arm | Type | Receives |
|---|---|---|
| İnfantile colic | Experimental | Dietary Supplement: Activia Probiotics Shot, Other: Routine careMothers of babies diagnosed with infantile colic in the intervention group will receive routine care and start taking probiotic products after the first stool of the babies and blood is taken for intestinal permeability and will continue for 15 days. |
| Control | Other | Other: Routine careMothers of babies diagnosed with infantile colic in the control group will receive routine care for 15 days after blood is taken for the first stool and intestinal permeability of the babies. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Mother's ability to speak Turkish,
- Single pregnancy,
- Delivery time is between 37 <GH <42 weeks,
- The mother does not have a chronic disease,
- Vaginal birth,
Key exclusion criteria (3 listed)
- Having problems with the breast in the mother,
- The mother is using probiotics / antibiotics before randomization and during her pregnancy,
- Mothers who are included in the study sample, take part in other clinical studies at the same time.
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 |
|---|---|---|
| Activia Probiotics ShotThe product contains Actiregularis - at least 2x106 cfu / g. | Dietary supplement | İnfantile colic |
| Routine careRoutine care of the hospital will be provided. | Other | Control, İnfantile colic |
Primary outcome
crying times
Time frame: up to 28 days
reduction of ≥50% of mean daily crying duration. The mothers will provided with a diary(according to the Barr Baby Diary) and they will instructed on how to complete it daily with data concerning administration of daily dose of the study product, number and duration of crying episodes. In addition, mothers will be trained to use stopwatches. They will keep the crying times daily.
microbiota analysis
Time frame: up to 28 days
stool sample.
5 secondary outcomes
Mother's depression
Time frame: up to 28 days
Binding
Time frame: up to 28 days
Babies' height (cm) anthropometric evaluation
Time frame: up to 28 days
weight (kg) anthropometric evaluation
Time frame: up to 28 days
head circumference (cm) anthropometric evaluation
Time frame: up to 28 days
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 7 Jun 2021.
- Derived from this study: PubMed 39715568Yildiz Karaahmet A, Dolgun G, Ozen M, Oguz D. Effect of Maternal Probiotics on Infantile Colic Symptoms and Maternal Quality of Life and Maternal Attachment: A Single-Blind, Randomized Controlled Study. Altern Ther Health Med. 2025 Mar;31(2):18-22.
- Derived from this study: PubMed 38655990Karaahmet AY, Dolgun G, Ozen M. Effects of probiotics on gastrointestinal symptoms, anthropometric measurements, and breastfeeding duration in infants with colic: a randomized control trial. Sao Paulo Med J. 2024 Apr 22;142(4):e2023069. doi: 10.1590/1516-3180.2023.0069.R1.31052023. eCollection 2024.
- Derived from this study: PubMed 36229024Yildiz Karaahmet A, Dolgun G, Ozen M. Probiotics added to maternal nutrition affect infantile colic symptoms and fecal microbiota profile: a single-blind randomized controlled study. Clin Exp Pediatr. 2022 Nov;65(11):547-554. doi: 10.3345/cep.2022.00766. Epub 2022 Sep 23.
- Individual participant dataSharing planned: Yes. The study protocol can be shared with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activia Probiotics Shot and Routine care in people with Infantile Colic and Microbial Colonization, run by Halic University at 1 site in Turkey (Türkiye).
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 14 inclusion and 3 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 7 Jun 2021. 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 Turkey (Türkiye). 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. 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?
crying times (time frame: up to 28 days). 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?
On the ClinicalTrials.gov record for NCT04374955, which also lists 3 linked publications.
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 7 Jun 2021.