Cheno Effect on Transit in Health and IBS-C

NCT00912301 | Completed Phase 2 Results

• 5 other identifiers: 08-001003R01DK054681R01DK079866UL1RR0241501RC1DK086182
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The study hypothesis is that the naturally occurring bile acid, chenodeoxycholic acid, induces acceleration of colonic transit in health and in patients with constipation-predominant Irritable Bowel Syndrome (IBS-C).

Conditions

Constipation-predominant Irritable Bowel Syndrome

Keywords

chenodeoxycholate, IBS, transit, colon, constipation

Outcome Measures

Primary Outcomes (1)

• Colonic Geometric Center at 24 Hours (GC24)

  The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.

  after 4 days of treatment

Secondary Outcomes (4)

• Colonic Transit at 48 Hours (GC48)

  after 4 days of treatment

• Ascending Colon Emptying (AC t_1/2)

  after 4 days' treatment

• Stool Consistency

  after 4 days' treatment

• Colonic Filling at 6 Hours

  after 4 days' treatment

Study Arms (3)

NaCDC 500 mg

EXPERIMENTAL

Participants randomized to this arm received 500 mg NaCDC per day for 4 days.

Drug: Sodium chenodeoxycholate (NaCDC)

NaCDC 1000 mg

EXPERIMENTAL

Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.

Drug: Sodium chenodeoxycholate (NaCDC)

Placebo

PLACEBO COMPARATOR

Participants randomized to this arm received a placebo capsule each day for 4 days.

Other: Placebo

Interventions

Sodium chenodeoxycholate (NaCDC) DRUG

500 or 1000 milligrams NaCDC per day each for a period of 4 days

Also known as: Chenodiol

NaCDC 1000 mg; NaCDC 500 mg

Placebo OTHER

Placebo capsules with identical appearance to the study drug were prepared by the Mayo Clinic research pharmacy.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers:
• Age (yr) 18-65
• Gender (F:M)3.5 :1
• Bowel Disease Questionnaire (BDQ) - IBS symptoms negative by Rome III criteria
• Hospital Anxiety/Depression score \<8
• IBS patients:
• Age (yr) 18-65
• Gender (F:M) 5 :1
• BDQ - IBS symptoms: positive by Rome III criteria
• Hospital Anxiety/Depression score: No restrictions

You may not qualify if:

• Abdominal surgery (except appendectomy or cholecystectomy)
• GI medications during the 48h prior to transit measurement
• Aspartate/Alanine transaminases \>2 X Upper Limit of Normal (ULN)
• Other Medications except stable doses of estrogen, thyroid, low dose antidepressants of the dopaminergic or serotonergic class

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Cremonini F, Mullan BP, Camilleri M, Burton DD, Rank MR. Performance characteristics of scintigraphic transit measurements for studies of experimental therapies. Aliment Pharmacol Ther. 2002 Oct;16(10):1781-90. doi: 10.1046/j.1365-2036.2002.01344.x.

  PMID: 12269971 BACKGROUND

• Rao AS, Wong BS, Camilleri M, Odunsi-Shiyanbade ST, McKinzie S, Ryks M, Burton D, Carlson P, Lamsam J, Singh R, Zinsmeister AR. Chenodeoxycholate in females with irritable bowel syndrome-constipation: a pharmacodynamic and pharmacogenetic analysis. Gastroenterology. 2010 Nov;139(5):1549-58, 1558.e1. doi: 10.1053/j.gastro.2010.07.052. Epub 2010 Aug 4.

  PMID: 20691689 RESULT

MeSH Terms

Conditions

Ichthyosis Bullosa of Siemens; Constipation

Interventions

Chenodeoxycholic Acid

Condition Hierarchy (Ancestors)

Ichthyosis; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Results Point of Contact

• Title: Michael L. Camilleri, MD
• Organization: Mayo Clinic

camilleri.michael@mayo.edu

507-266-2306

Study Officials

• Michael L. Camilleri, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 29, 2009
• First Posted: June 3, 2009
• Study Start: April 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 2, 2012
• Results First Posted: July 2, 2012

Record last verified: 2012-05

Locations

US (1)