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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT04374955
Study groupRoleWhat they receive
İnfantile colicExperimentalMothers 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
ControlOtherMothers 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.

  1. 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

  2. microbiota analysis

    stool sample.

    Measured: up to 28 days

Secondary outcomes (5)
  1. Mother's depression

    Evaluation of mothers' depression states will be evaluated by filling the "Beck Depression Inventory".

    Measured: up to 28 days

  2. Binding

    "Maternal Attachment Scale" will be filled in mothers to measure the attachment status between mother and baby.

    Measured: up to 28 days

  3. Babies' height (cm) anthropometric evaluation

    Measured: up to 28 days

  4. weight (kg) anthropometric evaluation

    Measured: up to 28 days

  5. 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.

  1. First posted5 May 2020
  2. Study start7 Oct 2020
  3. Primary completion1 Apr 2021
  4. Study completion1 Jun 2021

Resources

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)
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 39715568
  • Karaahmet 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 38655990
  • Yildiz 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

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.

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