Post-autorization study to compare the eficacy of the food supplement i3.1 and the antibiotic Rifaximin on SIBO (Small Intestinal Bacterial Overgrowth) reduction in patients suffering IBS (Irritable bowel syndrom).

Phase 1

• Conditions: Irritable Bowel Syndrome (IBS) + Small Intestinal Bacterial Overgrowth (SIBO); Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2019-002116-10-ES
• Lead Sponsor: AB-Biotics S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-02
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

18-65 years patients, diagnosed with IBS according to Roma IV (independently of the subtype) following the criteria:

•Positive for SIBO, (H2 and/or CH4), according to the Northamerican consensus.
•Start i3.1 intake.
•Signed informed consent.
•Able to understand and follow the indications and procedures of the protocol.
Patients taking a regular dosis of PIP or anstispasmodics are allowed to participate. Any regime alteration must be documented.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 46
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Use of antibiotics 4 weeks prior to study inclusion.
•Use of probiotics 2 weeks prior to study start.
•Use of loperamide or other prokinetics 1 week prior to study start.
•Use of Plantago ovata, lactulose or other laxatives 1 week prior to study start.
•Use of antidepressives.
•Suspect or diagnose of celiac disease, Sospecha o diagnostico confirmado de enfermedad celíaca, inflammatory bowel disease, diverticulitis or endomitriosis.
•Intestinal surgery (excluded appendectomy and herniorrhaphy).
•short bowel syndrome or pancreatitis.
•Treated with immunosupressors, cancer, severe cardiovascular disease, HIV, HBV or HCV-positives.
•Other diseases which may interfere with the effect of the i.3.1.
•Pregnant or breastfeeding.

Use of other antibiotics must be notified during study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to verify the ability of the probiotic i3.1 to reduce SIBO (determined through exhaled gas) in IBS patients and how the effect correlates with the symptomatic amelioration.;Secondary Objective: Study the effect of the probiotic in the intestinal microbiota at compositional taxonomical level and in specific intestinal anxiety. Besides, the efficacy of both treatments will be compared.;Primary end point(s): Change in exhaled gas from bacterial origin (CH4 y H2) measured as ppm (parts per million) by the analyzer GastroCHEKC® (Covita), after the intake of 25 gr of lactulose following the recommendations of the northamerican consensus.;Timepoint(s) of evaluation of this end point: baseline, 4w, 8w

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Change in the proportion of patients with an increase of =20 ppm of H2 after 90 min.<br>•Change in the proportion of patients with an increase of =10 ppm of CH4 after 90 min.<br>•Change in global symptoms of IBS, according to the IBS-SSS scale score.<br>•Change in the score of each of the 5 sub-scales in the IBS-SSS scale. <br>•Change in the score of each of gastrointestinal specific anxiety according to VSI scale.;Timepoint(s) of evaluation of this end point: baseline, 4w, 8w