Supplementation With Lacobacillus Reuteri ATCC PTA 4659 in Patients Affected by Acute Uncomplicated Diverticulitis

NCT03656328 | Completed

• 1 other identifier: 1398
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Acute Uncomplicated Diverticulitis (AUD) is defined as inflammation of the colon diverticulum, often involving the colic wall and pericolic fat. In a double-blind RCT study, the investigators tested the efficacy of Lactobacillus reuteri ATCC PTA 4659 (L. reuteri), a specific strain with anti-inflammatory effect in association with conventional antibiotics, in treating AUD, compared with conventional antibiotic therapy plus placebo. A primary outcome was reduced abdominal pain and inflammatory markers (C-RP) in the group treated with L. reuteri compared with the placebo. A secondary outcome was reduced hours of hospitalization in the L. reuteri group. A double-blind, placebo RCT was conducted with 90 consecutive patients with a diagnosis of AUD treated at the Emergency Department of Foundation Poli-clinico A. Gemelli Hospital. Following a routine blood test and determination of C-reactive protein (C-RP) value, all patients were admitted to the Brief Observation Unit (BOU) and randomly as-signed to two groups:

• Group A : Treated with ciprofloxacin 400 mg twice a day and metronidazole 500 mg three times a day for one week, plus supplementation with L. reuteri twice a day for 10 days.
• Group B : Treated with the same antibiotic therapy as Group A for one week, plus placebo twice a day for 10 days. All patients completed a daily Visual Analog Scale (VAS) for abdominal pain, with a range from 0 (asymptomatic) to 10. C-RP value was determined again at 72 hours.

Conditions

Acute Diverticulitis

Keywords

probiotics; inflammation markers

Outcome Measures

Primary Outcomes (1)

• reduction of abdominal pain

  evaluation with a Visual Analog Scale of abdominal pain between the two arms. The Visual Analog Scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured, like pain. it goes from 0 (asymptomatic) to 10 (the maximum pain).

  10 days

Secondary Outcomes (2)

• reduction of inflammatory markers

  72 hours

• comparisons of hours of hospitalization

  5 days

Study Arms (2)

Lactobacillus Reuteri 4659

EXPERIMENTAL

This Arm received standard antibiotic therapy, consisting of ciprofloxacin 400 mg twice a day and metronidazole 500 mg three times a day for seven days, with supplementation with the probiotic L. reuteri 4659 twice a day for 10 days

Dietary Supplement: Lactobacillus Reuteri 4659

Placebo

PLACEBO COMPARATOR

This arm received the same standard antibiotic therapy and a matching placebo for the same periods.

Dietary Supplement: Placebo

Interventions

Lactobacillus Reuteri 4659 DIETARY_SUPPLEMENT

supplementation with L. reuteri 4659 twice a day for 10 days during the standard antibiotic therapy

Lactobacillus Reuteri 4659

Placebo DIETARY_SUPPLEMENT

supplementation with a Placebo capsule twice a day for 10 days during the standard antibiotic therapy

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• No reported allergies to contrast agents or antibiotics
• Informed consent
• Diagnosis of AUD confirmed by abdomen CT scan

You may not qualify if:

• \<18 years
• Pregnancy or breastfeeding
• Concomitant or recent (7-10 days) participation in another clinical trial
• Concomitant or recent (7-15 days) intake of probiotics or antibiotics
• Major concurrent diseases (hepatological, renal, tumor)
• Inflammatory bowel disease (Crohn's disease, ulcerative colitis) or other organic gastrointestinal disease
• Allergies to contrast agents or antibiotics
• Mental illness or inability to adhere to protocols.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico universitario agostino gemelli

Roma, 00168, Italy

Location

Related Publications (1)

• Petruzziello C, Migneco A, Cardone S, Covino M, Saviano A, Franceschi F, Ojetti V. Supplementation with Lactobacillus reuteri ATCC PTA 4659 in patients affected by acute uncomplicated diverticulitis: a randomized double-blind placebo controlled trial. Int J Colorectal Dis. 2019 Jun;34(6):1087-1094. doi: 10.1007/s00384-019-03295-1. Epub 2019 Apr 22.

  PMID: 31011868 DERIVED

Study Officials

• Veronica Ojetti, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjuct Professor

Model Details: double blind

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 4, 2018
• Study Start: April 1, 2018
• Primary Completion: October 10, 2018
• Study Completion: December 30, 2018
• Last Updated: May 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)