Supplementation With Lacobacillus Reuteri ATCC PTA 4659 in Patients Affected by Acute Uncomplicated Diverticulitis
Primary Purpose
Acute Diverticulitis
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lactobacillus Reuteri 4659
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Diverticulitis focused on measuring probiotics, inflammation markers
Eligibility Criteria
Inclusion Criteria:
- Age >18 years
- No reported allergies to contrast agents or antibiotics
- Informed consent
- Diagnosis of AUD confirmed by abdomen CT scan
Exclusion Criteria:
- <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.
Sites / Locations
- Policlinico universitario agostino gemelli
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lactobacillus Reuteri 4659
Placebo
Arm Description
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
This arm received the same standard antibiotic therapy and a matching placebo for the same periods.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
reduction of inflammatory markers
evaluation of C-reactive Protein at enrollment and after 72 hours of therapy
comparisons of hours of hospitalization
comparison of hospitalization time between the two arms
Full Information
NCT ID
NCT03656328
First Posted
August 29, 2018
Last Updated
April 29, 2022
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT03656328
Brief Title
Supplementation With Lacobacillus Reuteri ATCC PTA 4659 in Patients Affected by Acute Uncomplicated Diverticulitis
Official Title
Supplementation With Lacobacillus Reuteri ATCC PTA 4659 in Patients Affected by Acute Uncomplicated Diverticulitis : a Randomized Double-blind Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
October 10, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
Detailed Description
Patients are evaluated in a clinical setting by a physician at enrolment in the study, every day during hospitalization, and at the end of therapy. At enrolment, a medical history review (including drugs taken), physical examination, laboratory tests (blood cell count, hepatic and renal function, electrolytes, C-RP) and abdominal CT scan were performed.
All patients presented with AUD (Hinchey classification grade 0). All patients were given a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 is asymptomatic and 10 is the worst pain they could have, to complete during the 10 days of the study.
Patients were also asked to complete a diary, in order to record any 'adverse experience' (causing discomfort and/or interrupting the subject's usual activity) during the treatment periods, and to record every time they did not consume the prescribed doses. The diary was analyzed by physicians.
The patients are randomly assigned into two groups, according to an automatically generated randomization list in a 1:1 ratio, using statistical software:
Group A 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.
Group B received the same standard antibiotic therapy as group A and a matching placebo for the same periods.
Patients were informed by an investigator (blind) that such a supplement could help in improving the inflammation associated with diverticulitis. Boxes containing placebo had the same shape dimensions, and trade mark indication and contained the same amount of capsules as L. reuteri boxes, and they were provided by the same probiotic producer.
The supplement of L. reuteri 4659 was administered in a dose of 108 colony-forming units (CFU), in capsules 30 minutes after food. During the study period, patients were instructed to store the product according to the recommended temperature. In particular, the capsules could be stored at room temperature (25°C). Because L. reuteri is a living organism, over long storage periods it is preferable not to freeze the capsules, but to refrigerate them at 2-8°C.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Diverticulitis
Keywords
probiotics, inflammation markers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double blind
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactobacillus Reuteri 4659
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This arm received the same standard antibiotic therapy and a matching placebo for the same periods.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus Reuteri 4659
Intervention Description
supplementation with L. reuteri 4659 twice a day for 10 days during the standard antibiotic therapy
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
supplementation with a Placebo capsule twice a day for 10 days during the standard antibiotic therapy
Primary Outcome Measure Information:
Title
reduction of abdominal pain
Description
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).
Time Frame
10 days
Secondary Outcome Measure Information:
Title
reduction of inflammatory markers
Description
evaluation of C-reactive Protein at enrollment and after 72 hours of therapy
Time Frame
72 hours
Title
comparisons of hours of hospitalization
Description
comparison of hospitalization time between the two arms
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >18 years
No reported allergies to contrast agents or antibiotics
Informed consent
Diagnosis of AUD confirmed by abdomen CT scan
Exclusion Criteria:
<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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica Ojetti, MD
Organizational Affiliation
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico universitario agostino gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31011868
Citation
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.
Results Reference
derived
Learn more about this trial
Supplementation With Lacobacillus Reuteri ATCC PTA 4659 in Patients Affected by Acute Uncomplicated Diverticulitis
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