Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
117 participants
INTERVENTIONAL
2007-11-30
2010-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Rifaximin Delayed Release for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications.
NCT03469050
Diverticulitis: Antibiotics or Close Observation?
NCT01111253
Trial Assessing the Efficacy of a Short Course of Intravenous Antibiotic Followed by Oral Antibiotic in Uncomplicated Acute Diverticulitis
NCT00917592
Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. Placebo in Acute Uncomplicated Diverticulitis
NCT01847664
Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome
NCT00269412
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mesalamine
Days 1 thru 10-14 (Visit 2): daily antibiotic therapy, dietary advice and 6 - 400 mg mesalamine tablets once a day. Visit 2 thru Week 12: 1 placebo capsule (matching probiotic) and 6 - 400 mg mesalamine tablets daily.
Mesalamine
6 - 400 mg tablets once daily
Dietary Advice
Dietary advice
Antibiotic for Diverticulitis
Physician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.
Mesalamine & Probiotic
Days 1 thru 10-14 (Visit 2): daily antibiotic therapy, dietary advice and 6 - 400 mg mesalamine tablets once daily. Visit 2 thru Week 12: 1- Bifidobacterium infantis 35624 capsule and 6 - 400 mg mesalamine tablets daily
Probiotic
Once capsule daily Bifidobacterium infantis 35624 added at Visit 2 (Day 10 + 4 days)
Dietary Advice
Dietary advice
Antibiotic for Diverticulitis
Physician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.
Placebo
Days 1 thru Days 10 to 14 (Visit 2): daily antibiotic therapy, dietary advice, and 6 placebo tablets (matching mesalamine) once a day. Visit 2 thru Week 12 : 1 placebo capsule (matching probiotic) and 6 placebo tablets (matching mesalamine) daily.
Placebo
6 placebo tablets for first 10 (+4) days followed by once daily placebo tablets.
Dietary Advice
Dietary advice
Antibiotic for Diverticulitis
Physician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mesalamine
6 - 400 mg tablets once daily
Probiotic
Once capsule daily Bifidobacterium infantis 35624 added at Visit 2 (Day 10 + 4 days)
Placebo
6 placebo tablets for first 10 (+4) days followed by once daily placebo tablets.
Dietary Advice
Dietary advice
Antibiotic for Diverticulitis
Physician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Female patients must be postmenopausal (at least 1 year without spontaneous menses) or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception (e.g., abstinence; oral, intramuscular, or implanted hormonal contraception \[at least 3 months prior to enrollment\]; 2-barrier methods \[e.g., condom, diaphragm, or spermicide\]; intrauterine device or verbal report of partner with history of non-reversed vasectomy)
* Willing and able to participate in the study and provide a signed informed consent
Exclusion Criteria
* Active or recent history (within 6 months) of a peptic ulcer;
* Prior history of irritable bowel syndrome (IBS), as determined by the Investigator;
* History of major abdominal surgery (as determined by the Investigator);
* History of GI surgery within 3 months of diagnosis of acute diverticulitis;
* History of immunocompromising disease, human immunodeficiency virus (HIV) infection, or acquired immunodeficiency syndrome (AIDS);
* If female patient, active or recent history of endometriosis or dysmenorrhea;
* Received a dose of a product that contains, or is metabolized to, mesalamine by any route within 4 weeks before the screening visit;
35 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Warner Chilcott
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ana Balske, MD, PhD
Role: STUDY_DIRECTOR
Procter and Gamble
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Tucson, Arizona, United States
Research Facility
Los Angeles, California, United States
Research Site
Merced, California, United States
Research Site
Oakland, California, United States
Research Facility
Orange, California, United States
Research Site
Palm Springs, California, United States
Research Site
Pasadena, California, United States
Research Site
Lafayette, Colorado, United States
Research Site
Littleton, Colorado, United States
Research Site
Boynton Beach, Florida, United States
Research Site
Jacksonsville, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Winter Park, Florida, United States
Research Facility
Zephyrhills, Florida, United States
Research Site
Pratt, Kansas, United States
Research Site
Monroe, Louisiana, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Chesterfield, Michigan, United States
Research Site
Tupelo, Mississippi, United States
Research Site
Mexico, Missouri, United States
Research Facility
Cedar Knolls, New Jersey, United States
Research Site
Great Neck, New York, United States
Research Site
Lake Success, New York, United States
Research Site
Setauket, New York, United States
Research Site
Asheville, North Carolina, United States
Research Site
Greenville, North Carolina, United States
Research Facility
Harrisburg, North Carolina, United States
Research Site
Morganton, North Carolina, United States
Research Site
Wilmington, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cranston, Rhode Island, United States
Research Site
Longview, Texas, United States
Research Site
Odessa, Texas, United States
Research Site
Chesapeake, Virginia, United States
Research Facility
Monroe, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Stollman N, Magowan S, Shanahan F, Quigley EM; DIVA Investigator Group. A randomized controlled study of mesalamine after acute diverticulitis: results of the DIVA trial. J Clin Gastroenterol. 2013 Aug;47(7):621-9. doi: 10.1097/MCG.0b013e31828003f6.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2007020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.