Lactobacillus Reuteri Versus Placebo in the Treatment and Prevention of Infantile Colic

  • days left to enroll
  • participants needed
  • sponsor
    Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Updated on 23 January 2022
vit d
vitamin d3
fecal calprotectin
infantile colic
messenger rna
dna sequencing
quantitative immunoassay
16s ribosomal rna


The purpose of this study is:

  • to study the intestinal microflora of colicky infants before and after L. reuteri or placebo administration, evaluating the effect of Lactobacillus reuteri on the growth of the main intestinal microbiota (coliforms, Clostridium butyricum, Lactobacilli, Bifidobacteria) with fluorescent in situ hybridization (FISH) technique or with Real-Time PCR Taqman; Further, the global intestinal microflora composition, using large-scale DNA sequencing of 16S rRNA genes ( 454-pyrosequencing technique.
  • to evaluate the improvement of colicky symptoms by the oral administration of Lactobacillus reuteri (primary outcome: reduction of the daily average crying time from baseline to the end of the treatment period, to less than 3 hours a day, the cut-off proposed by Wessel; secondary outcome: number of responders versus non-responders in each group at the end of the treatment).
  • to evaluate fecal calprotectin values at the beginning and at the end of the study. BHLMANN Quantum Blue Calprotectin High Range (Schnenbuch, Switzerland). A quantitative immunoassay.
  • to evaluate Th17/Treg balance at time 0 and t 30 ( days) investigating mRNA FOXP3 and ROR in peripheral blood using RT-PCR Real Time Taqman.
  • the measurement of the expression level of CC-chemokine receptor 7 messenger RNA using the real-time TaqMan reverse transcription polymerase chain reaction method.
  • the measurement of expression of interleukin 10 (IL-10) messenger RNA using the real-time TaqMan reverse transcription polymerase chain reaction method.
  • Parental satisfaction at the end of the study period ( 30 day ) with a numerc scale from 1 to 10.


Infantile colic is one of the most common problems within the first three months of life. It consists of a behavioural syndrome characterised by paroxysmal, excessive and inconsolable crying without identifiable cause. Although infantile colic is commonly reported and causes appreciable distress for both parents and paediatricians, despite forty years of research, its aetiology still remains unclear. Recently the role of intestinal microflora has growing importance, and a lower count of intestinal lactobacilli has been observed in colicky infants compared to healthy ones. In a recent study we have observed that Lactobacillus reuteri improved colicky symptoms in breast-fed infants within one week of treatment compared to Simethicone, suggesting that probiotics may play a role in infantile colic (Savino F, Pelle E, Palumeri E, Oggero R, Miniero R.Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics 2007; 119:e124-30). The mechanism involved in such finding is only partially understood and, for this reason, we have planned this new study to evaluate not only the clinical improvement but also the microbiological data.

Condition Infantile Colic
Treatment Placebo, Lactobacillus reuteri DSM 17938, L.reuteri + Vit D, Vit D placebo
Clinical Study IdentifierNCT00893711
SponsorAzienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Last Modified on23 January 2022


Yes No Not Sure

Inclusion Criteria

clinical diagnosis of infantile colic according to Wessel's criteria
gestational age between 37 and 42 weeks
age between 4 and 16 weeks
birth weight between 2500 and 4000 g
exclusively breastfed

Exclusion Criteria

clinical evidence of chronic illness or gastrointestinal disorders
administration of probiotics and antibiotics
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note