Acute DiverticulitisNCT03656328
Supplementation With Lacobacillus Reuteri ATCC PTA 4659 in Patients Affected by Acute Uncomplicated Diverticulitis
A study testing Lactobacillus Reuteri 4659 in people with Acute Diverticulitis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Diverticulitis
- What is being tested?
- Lactobacillus Reuteri 4659
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2018to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- No reported allergies to contrast agents or antibiotics
- Informed consent
- Diagnosis of AUD confirmed by abdomen CT scan
Who cannot join
- <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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supplementation With Lacobacillus Reuteri ATCC PTA 4659 in Patients Affected by Acute Uncomplicated Diverticulitis : a Randomized Double-blind Placebo Controlled Trial
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:
Read more
- 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.
Read the 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.
- Conditions
- Acute Diverticulitis
- Being tested
- Lactobacillus Reuteri 4659, Placebo
- Keywords
- probiotics, inflammation markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus Reuteri 4659Dietary supplement
supplementation with L. reuteri 4659 twice a day for 10 days during the standard antibiotic therapy
PlaceboDietary supplement
supplementation with a Placebo capsule twice a day for 10 days during the standard antibiotic therapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Lactobacillus Reuteri 4659 |
| Placebo | Placebo comparator | This arm received the same standard antibiotic therapy and a matching placebo for the same periods. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 days
Secondary outcomes (2)
reduction of inflammatory markers
evaluation of C-reactive Protein at enrollment and after 72 hours of therapy
Measured: 72 hours
comparisons of hours of hospitalization
comparison of hospitalization time between the two arms
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start1 Apr 2018
- Primary completion10 Oct 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute DiverticulitisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OJETTI VERONICA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Veronica Ojetti, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656328
- Sponsor's protocol ID
- 1398
- Status last verified
- Apr 2022
- First submitted
- 29 Aug 2018
- Last updated
- 5 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31011868
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation With Lacobacillus Reuteri ATCC PTA 4659 in Patients Affected by Acute Uncomplicated Diverticulitis : a Randomized Double-blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03656328
- Acronym / sponsor ID
- 1398
- Conditions
- Acute Diverticulitis
- Keywords
- probiotics, inflammation markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 4 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- double blind
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus Reuteri 4659 | Experimental | Dietary Supplement: Lactobacillus Reuteri 4659This 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 |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis arm received the same standard antibiotic therapy and a matching placebo for the same periods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years
- No reported allergies to contrast agents or antibiotics
- Informed consent
- Diagnosis of AUD confirmed by abdomen CT scan
Key exclusion criteria (8 listed)
- <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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus Reuteri 4659supplementation with L. reuteri 4659 twice a day for 10 days during the standard antibiotic therapy | Dietary supplement | Lactobacillus Reuteri 4659 |
| Placebosupplementation with a Placebo capsule twice a day for 10 days during the standard antibiotic therapy | Dietary supplement | Placebo |
Primary outcome
reduction of abdominal pain
Time frame: 10 days
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).
2 secondary outcomes
reduction of inflammatory markers
Time frame: 72 hours
comparisons of hours of hospitalization
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Derived from this study: PubMed 31011868Petruzziello 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.
- Individual participant dataSharing planned: No
Related trials for Acute Diverticulitis
RecruitingObservational study
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Complicated Diverticulitis, Acute Diverticulitis
Not yet recruiting
Improving the Treatment of Acute Uncomplicated Diverticulitis in Routine Care
Diverticulitis
RecruitingPhase 2
APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)
Acute Uncomplicated Diverticulitis
Not yet recruitingObservational study
Analysis of the Role of the Microbiota in Diverticular Disease
Diverticular Disease of Colon, Acute Diverticulitis
RecruitingObservational study
Diagnosis of Abdominal Pain Using RNA Levels: The NATURAL Study
Intra Abdominal Infections, Appendicitis Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronica Ojetti, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus Reuteri 4659 in people with Acute Diverticulitis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of abdominal pain (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03656328, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.