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Diverticulitis / Diverticulosis

General Purpose:

Diverticula are marble-sized, bulging pouches that can form anywhere in the digestive system, however, they most often form in the large intestines. The presence of diverticula is referred to as diverticulosis. Diverticulosis is common in individuals over the age of 40, and most people never know that they even have it, as diverticula rarely cause any problems.

However, on occasion, diverticula can become inflamed or even infected, leading to severe abdominal pain, fever, nausea, and changes in bowel movements. This condition is known as diverticulitis.

The reasons why diverticulitis occurs are not well understood. Some researchers think that increased pressure within the colon causes diverticula to weaken and open up, increasing the chance of infection. Others believe that diverticula actually trap fecal matter, which can also lead to infection.

Inflammation may result due to the obstruction of blood flow to the area. Historically, doctors and researchers believed that nuts, seeds, popcorn, and other small food particles might become trapped in the diverticula and lead to diverticulitis; however, recent research has demonstrated that this is not the case.

Apart from being over the age of 40, there are only a few other known risk factors associated with an increased risk of diverticulitis. These include a diet that is low in fiber, physical inactivity, obesity, and smoking.

If left untreated, diverticulitis can result in serious complications. These include peritonitis (inflammation of the lining of the abdominal cavity), rectal bleeding, intestinal blockage, abscess, or a fistula. A fistula is an abnormal passageway that occurs between two parts of the intestines, between the intestines and the bladder or vagina, or between the intestines and abdominal walls.

Fistulas can open the door for infection and other adverse side effects. Diverticulosis can also make colon and rectal cancer more difficult to diagnose.

Research is underway to investigate both diverticulosis and diverticulitis on a number of fronts. Some researchers are investigating a potential link between diverticulosis and inflammatory bowel disease, while others are hard at work developing better treatments for managing diverticulosis.

Probiotic medications (bacteria-based medicines that are similar to the active cultures found in yogurt) are also being tested for their usefulness in treating a variety of digestive illnesses, including diverticulitis, and surgical approaches to treating diverticulitis are also being tested.

What Will Diverticulitis / Diverticulosis Clinical Trials Be Like?

The types of tests and assessments used in clinical trials for diverticulosis and/or diverticulitis will ultimately depend on the specific nature of the study. Provided below is a list of frequent procedures and tests that may be incorporated into clinical trials:

  • Physical exam and detailed medical history
  • Blood tests to look for signs of infection
  • Computed tomography (CT, or “CAT scan”): an imaging procedure that uses an x-ray machine linked to a computer to take detailed pictures of areas inside the body.
  • Barium enema X-ray: this procedure involves the use of a barium-containing enema, which coats the bowels and allows them to be more visible on x-ray.
  • Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug.
  • Pain and quality of life assessments, as well as diet, exercise and/or medication diaries, may also be required in some studies, depending on the research question being studied.

Typical Diverticulitis / Diverticulosis Clinical Trial Protocol:

Specific examples of clinical trials for diverticulitis/diverticulosis might include the following:

  • A long-term randomized clinical trial to evaluate the effectiveness of an anti-inflammatory medication when used to prevent diverticulitis flare-ups among individuals with diverticulosis who have had at least three prior flares. In such a study, half of the patients would be randomly assigned to receive either treatment with the anti-inflammatory medication or a placebo over a two year period.
  • A randomized clinical trial to evaluate the use of a newly-discovered probiotic bacteria (similar to the active cultures found in yogurt) in obese individuals with diverticulosis. In such a study, half of the patients would be randomly assigned to receive treatment with the bacterial medication, while the other half would be randomly assigned to receive a placebo.
  • A randomized clinical trial to evaluate if short-term (48 hour) antibiotic therapy following a diverticulitis flare-up is more effective at relieving symptoms than long-term (7 day) antibiotic therapy.
  • An observational study in which individuals who are diagnosed with diverticulosis during routine colonoscopy provide a sample of their diverticular tissue (via biopsy), a blood sample, and a fecal matter sample for analysis. Such a study would allow researchers to examine the biological samples to gain a better understanding of the nature of diverticulosis.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug or intervention, compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated, the investigational treatment might be compared to a placebo alone (such as in the first two clinical trial examples provided above). In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

  • Your history of diverticulitis
  • Any underlying illnesses you have
  • Your current medications (including aspirin), vitamins, and dietary supplements
  • Your history of treatment for diverticulitis

Suggested Search Terms:

Once you are ready to begin your search for diverticulosis / diverticulitis clinical trials, the following terms may be of use when combined with either “diverticulitis” or “diverticulosis”: “prevention,” “management,” “treatment,” “diet,” “exercise,” “disease,” “elderly,” “side effects,” “medication,” “surgery,” and “diagnosis.”

You may also find trials of interest when you search using the phrase “diverticular disease.”

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Fecal Calprotectin Collection Protocol

Conditions:   Inflammatory Bowel Diseases;   Irritable Bowel Syndrome;   Ulcerative Colitis;   Crohn Disease;   Indeterminate Colitis;   Chronic Diarrhea;   Celiac Disease;   Diverticulitis;   Abdominal Pain;   Distension;   Weight Loss;   Food Intolerance;   Constipation
Intervention:   Diagnostic Test: Stool collection
Sponsors:   DiaSorin Inc.;   ICON Clinical Research
Recruiting - verified May 2017

Outpatient Treatment of Uncomplicated Diverticulitis With Either Antibiotic or Nonantibiotic Treatment

Condition:   Uncomplicated Diverticular Disease
Interventions:   Other: Nonantibiotic treatment of uncomplicated diverticulitis;   Other: Antibiotic treatment of uncomplicated diverticulitis
Sponsor:   Jewish General Hospital
Not yet recruiting - verified May 2017

Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery

Conditions:   Colorectal Neoplasms;   Diverticulitis;   Inflammatory Bowel Diseases;   Surgical Site Infection
Interventions:   Drug: Polyethylene Glycol;   Drug: Neomycin;   Drug: Metronidazole Hydrochloride;   Procedure: Therapeutic Conventional Surgery
Sponsor:   Sidney Kimmel Cancer Center at Thomas Jefferson University
Recruiting - verified February 2017

Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis : a Multicenter Prospective Observational Study (STELLA Study)

Condition:   Acute Diverticulitis
Intervention:   Procedure: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites
Sponsors:   Azienda Ospedaliero, Universitaria Pisana;   Ospedale San Jacopo, Pistoia;   S. Andrea Hospital;   Maggiore Bellaria Hospital, Bologna;   Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Recruiting - verified December 2016

Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery

Conditions:   Colon Cancer;   Colon Diverticulosis;   Colonic Neoplasms;   Colonic Diverticulitis;   Pain, Postoperative;   Ileus;   Ileus Paralytic;   Ileus; Mechanical;   Constipation Drug Induced;   Constipation;   Rectum Cancer;   Rectum Neoplasm
Interventions:   Drug: Acetaminophen;   Drug: Gabapentin;   Drug: Orphenadrine;   Drug: Lidocaine;   Drug: Marcaine;   Drug: Ketamine;   Drug: Methadone;   Drug: Tramadol;   Drug: Ketorolac;   Drug: Morphine Sulfate;   Drug: Fentanyl;   Drug: Dilaudid;   Drug: Hydrocodone-Acetaminophen Tab 5-325 MG;   Drug: Morphine Sulfate;   Drug: Fentanyl;   Drug: Dilaudid;   Drug: HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLET
Sponsor:   University of Illinois College of Medicine at Peoria
Recruiting - verified March 2017

Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells in Inflammatory Bowel Disease

Condition:   Inflammatory Bowel Diseases
Interventions:   Procedure: Lipoaspiration;   Procedure: AD-cSVF;   Procedure: Normal Saline IV
Sponsors:   Healeon Medical Inc;   Glenn Terry, MD
Recruiting - verified March 2017

PCT REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study

Condition:   Acute Diverticulitis
Interventions:   Procedure: Measure PCT, CRP and WBC at admission;   Procedure: Measure PCT, CRP and WBC 1 day after admission;   Procedure: Measure PCT, CRP and WBC 2 days after admission
Sponsor:   University of Roma La Sapienza
Recruiting - verified June 2016

Point of Care 3D Ultrasound for Various Applications: A Pilot Study

Conditions:   Appendicitis;   Evidence of Cholecystectomy;   Gallstones;   Pregnancy, Ectopic;   Aortic Aneurysm;   Kidney Stones;   Intrauterine Pregnancy;   Diverticulitis;   Abdominal Injuries;   Tumors;   Pancreatitis;   Digestive System Diseases;   Gastrointestinal Diseases;   Intraabdominal Infections;   Intestinal Diseases;   Pregnancy;   Vascular Disease;   Uterine Fibroids;   Ovarian Cysts;   Uterine Abnominalies;   Bladder Abnominalies;   Testicular Abnominalies;   Polyps
Sponsors:   Duke University;   Wallace H. Coulter Foundation
Recruiting - verified March 2017

Randomized Clinical Trial to Compare the Treatment of Mild Acute Diverticulitis With or Without Antibiotics

Condition:   Acute Diverticulitis
Interventions:   Drug: Ibuprofen;   Drug: Acetaminophen;   Drug: Amoxicillin/clavulanic acid
Sponsor:   Corporacion Parc Tauli
Recruiting - verified January 2017

DEBUT: Diverticulitis Evaluation of Patient Burden, Utilization, and Trajectory

Condition:   Diverticulitis
Sponsors:   University of Washington;   National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Recruiting - verified May 2017

Multicentric Point of Care UltraSound by Surgeons Trial

Conditions:   Biliary Calculi;   Cholecystitis, Acute;   Cholecystitis, Chronic;   Cholelithiasis;   Calculus of Bile Duct With Cholangitis;   Acute Diverticulitis;   Diverticulosis;   Colitis;   Perforation of Colon;   Abscess
Interventions:   Device: Bedside performed Ultrasound Scan by the surgeon;   Other: Radiology report;   Procedure: Intra-operative findings
Sponsors:   Connolly Hospital Blanchardstown;   Royal College of Surgeons in Ireland (RCSI);   Modular UltraSound ESTES Course (MUSEC);   European Society for Trauma and Emergency Surgery (ESTES)
Recruiting - verified April 2017

Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis

Conditions:   Sigmoid Diverticulosis;   Sigmoid Diverticulitis;   Colorectal Malignancy
Intervention:   Procedure: Left-sided colonic resection
Sponsor:   IHU Strasbourg
Recruiting - verified August 2016

Randomized Clinical Trial for the Uncomplicated Diverticulitis in Right Colon

Condition:   Simple Diverticular Disease
Intervention:   Drug: Cephalosporin + Metronidazole
Sponsor:   Dongtan Sacred Heart Hospital
Active, not recruiting - verified April 2016

Using Electrical Bioimpedance Assessments to Estimate Perioperative Total Body Water and Postoperative Fluid Need

Conditions:   Intestinal Cancer;   Diverticulitis;   Pancreatic Cancer;   Gastroesophageal Reflux Disease
Intervention:   Device: Bodystat Quadscan 4000
Sponsor:   United States Naval Medical Center, Portsmouth
Completed - verified September 2016

Effect of a Probiotic on Diverticular Symptoms

Condition:   Diverticular Disease
Intervention:   Dietary Supplement: Probiotic
Sponsor:   King's College Hospital NHS Trust
Completed - verified April 2014

Single Port Colic Laparoscopic Surgery

Conditions:   Colonic Neoplasms;   Crohn's Disease;   Diverticulitis
Interventions:   Procedure: single port surgery;   Procedure: Multiport surgery
Sponsors:   Assistance Publique - Hôpitaux de Paris;   Fondation de l'Avenir
Recruiting - verified August 2016

Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. Placebo in Acute Uncomplicated Diverticulitis

Condition:   Uncomplicated Diverticulitis
Interventions:   Drug: Rifamycin SV-MMX® 400 mg b.i.d.;   Drug: Rifamycin SV-MMX® 600 mg t.i.d.;   Drug: Rifamycin SV-MMX® Placebo
Sponsor:   Dr. Falk Pharma GmbH
Recruiting - verified February 2017

A Randomized Trial on the Technical Aspects of Stoma Construction.

Conditions:   Colostomy;   Colorectal Neoplasm;   Diverticulitis
Interventions:   Procedure: Cruciate incision;   Procedure: Circular incision;   Other: Mesh enforced cruciate incision
Sponsors:   Sahlgrenska University Hospital, Sweden;   The Swedish Society of Medicine;   The Swedish agreement concerning research and education of doctors
Recruiting - verified October 2016

Scandinavian Diverticulitis Trial

Condition:   Diverticulitis
Intervention:   Procedure: Surgery for acute perforated diverticulitis
Sponsors:   University Hospital, Akershus;   Sykehuset Asker og Baerum;   Diakonhjemmet Hospital;   Sykehuset Ostfold;   Haukeland University Hospital;   Sykehuset Innlandet HF;   Karolinska University Hospital;   University Hospital, Linkoeping;   Levanger Hospital;   Skane University Hospital;   Helse Nordmøre og Romsdal;   Ullevaal University Hospital;   Helse Stavanger HF;   Helse Nord;   Uppsala University Hospital;   Centrallasarettet Västerås;   Sykehuset Buskerud HF;   Helsingborgs Hospital;   Vrinnevisjukhuset i Norrköping;   Eskilstuna Lasarettet
Completed - verified January 2017

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