Lactobacillus Reuteri Strain Combination in Children Treated With PPI

NCT05484128 | Recruiting

• 1 other identifier: PROBPPI
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

Probiotics might be of help in preventing dysbiosis and emergence of SIBO. Gastrus consisted of a mixture of two human strains of L. Reuteri DSM 17938 and ATCC PTA 6475; the first have extensive data supporting its use in gastric infections (18) however, it lacks the anti-inflammatory properties that have been provided by L. Reuteri DSM ATCC PTA 6475 that has excellent acid resistance and has strong anti-inflammatory properties (19); for these reasons, Gastrus is the best candidate for this indication.

Conditions

Gastric Lesion; Proton Pump Inhibitor Adverse Reaction; Probiotic

Keywords

Reuteri; Proton Pump Inhibitor; gastrus; infections

Outcome Measures

Primary Outcomes (2)

• Variation in Lactulose breath test results

  This study aimed at investigating if Gastrus administration prevents the emergence of SIBO in children treated with proton pump inhibitors. This test will be performed to assess the presence of SIBO before PPI treatment and at week 10 (end of PPI treatment).

  at baseline and week 10

• Variation in results of Health Questionnaire for Data Collection

  A diary will be given to the parents, with instructions to report the following: systemic symptoms including fever, headache, restless, myalgia, irritability; gastrointestinal or respiratory symptoms; use of drugs (antibiotics, antipyretics, steroids); emergency department medical examinations; hospitalizations; possible adverse events; consumption of the study products; school days lost by the children; working days lost by the parents.

  at baseline and weekly until week 14

Secondary Outcomes (2)

• fecal analysis

  14 weeks

• Gastrointestinal Symptom Rating Scale (GSRS).

  14 weeks

Study Arms (2)

Gastrus

EXPERIMENTAL

86 patients Gastrus sachets/chewable caps: 2x108 CFU Lactobacillus reuteri DSM 17938 + 2x108 CFU Lactobacillus reuteri ATCC PTA 6475. Placebo sachets/chewable caps: Identical in shape, colour and taste to Gastrus capsules but without the Lactobacillus reuteri components. Both study products are delivered in identical containers. Dosing: Two sachets/cps twice a day. Length of treatment: Gastrus or placebo will be administered for all the duration of PPI administration (8 weeks) plus two weeks after its discontinuation. A final evaluation will be performed 4 weeks after the discontinuation of both Gastrus and placebo.

Dietary Supplement: Gastrus

Placebo

PLACEBO COMPARATOR

86 patients Gastrus sachets/chewable caps: 2x108 CFU Lactobacillus reuteri DSM 17938 + 2x108 CFU Lactobacillus reuteri ATCC PTA 6475. Placebo sachets/chewable caps: Identical in shape, colour and taste to Gastrus capsules but without the Lactobacillus reuteri components. Both study products are delivered in identical containers. Dosing: Two sachets/cps twice a day. Length of treatment: Gastrus or placebo will be administered for all the duration of PPI administration (8 weeks) plus two weeks after its discontinuation. A final evaluation will be performed 4 weeks after the discontinuation of both Gastrus and placebo.

Other: Placebo

Interventions

Gastrus DIETARY_SUPPLEMENT

Gastrus consisted of a mixture of two human strains of L. Reuteri DSM 17938 and ATCC PTA 6475. Gastrus will be administered for all the duration of PPI administration (8 weeks) plus two weeks after its discontinuation. A final evaluation will be performed 4 weeks after the discontinuation of both Gastrus.

Gastrus

Placebo OTHER

placebo has an identical preparation to Gastrus

Placebo

Eligibility Criteria

• Age: 12 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: children between 1 month and 14 years of age;
• o We start with children older than 4 years of age.
• Necessity of therapy with Proton Pump Inhibitors for Gastroesophageal reflux disease and/or Functional Dyspepsia;
• Informed consent obtained.

You may not qualify if:

• Neurological pathologies (PCI and Spastic tetra-paresis);
• Nasogastric feeding;
• Known immunodeficiency;
• Previous therapy with gastric acid inhibitors;
• HP infection;
• Assumption of prebiotics, other probiotics or symbiotics in the previous month;
• Malnutrition or severe dystrophy;
• Cystic Fibrosis.

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Fernanda

Bari, 70100, Italy

RECRUITING

Related Publications (3)

• Kahrilas PJ, Shaheen NJ, Vaezi MF, Hiltz SW, Black E, Modlin IM, Johnson SP, Allen J, Brill JV; American Gastroenterological Association. American Gastroenterological Association Medical Position Statement on the management of gastroesophageal reflux disease. Gastroenterology. 2008 Oct;135(4):1383-1391, 1391.e1-5. doi: 10.1053/j.gastro.2008.08.045. No abstract available.

  PMID: 18789939 RESULT

• Wandall JH. Effects of omeprazole on neutrophil chemotaxis, super oxide production, degranulation, and translocation of cytochrome b-245. Gut. 1992 May;33(5):617-21. doi: 10.1136/gut.33.5.617.

  PMID: 1319381 RESULT

• DELLIPIANI AW, GIRDWOOD RH. BACTERIAL CHANGES IN THE SMALL INTESTINE IN MALABSORPTIVE STATES AND IN PERNICIOUS ANAEMIA. Clin Sci. 1964 Jun;26:359-74. No abstract available.

  PMID: 14191265 RESULT

MeSH Terms

Conditions

Infections

Central Study Contacts

ruggiero francavilla, professor

CONTACT

0805592847; ruggiero.francavilla@uniba.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: nobody knows the randomization code
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Ruggiero Francavilla

Model Details: randomized double bind with placebo

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: August 2, 2022
• Study Start: March 4, 2020
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

IT (1)