ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000021411
Date of registration:	01/04/2016
Prospective Registration:	Yes
Primary sponsor:	Keio University, School of Medicine
Public title:	clinical efficacy of oral administration of metronidazole in the treatment of primary sclerosing cholangitis
Scientific title:	clinical efficacy of oral administration of metronidazole in the treatment of primary sclerosing cholangitis - clinical efficacy of oral administration of metronidazole in the treatment of PSC
Date of first enrolment:	2016/04/01
Target sample size:	20
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024696
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Not applicable

Countries of recruitment
Japan

Contacts

Name:	Nobuhiro Nakamoto
Address:	35 Shinanomachi Shinjuku-ku, Tokyo
Telephone:	+81-3-3353-1211
Email:	nobuhiro@z2.keio.jp
Affiliation:	Keio University, School of Medicine Division of Gastroenterology and Hepatology

Name:	Nobuhiro Nakamoto
Address:	35 Shinanomachi Shinjuku-ku, Tokyo
Telephone:	+81-3-3353-1211
Email:	nobuhiro@z2.keio.jp
Affiliation:	Keio University, School of Medicine Division of Gastroenterology and Hepatology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: Patients with a decompensated cirrhosis (Child Pugh score upper 10 point)

Age minimum: 16years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

primary sclerosing cholangitis

Intervention(s)

Patients take metronidazole 250mg orally three times day for 3 weeks.

Primary Outcome(s)

Serological improvement in the hepatobiliary function (serum ALP and total bilirubin) at 12weeks after the treatment

Secondary Outcome(s)

Alteration of the intestinal flora during the treatment

Secondary ID(s)

Source(s) of Monetary Support

Keio University, School of Medicine

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date: 22/02/2016
Contact:

Results

Results available:	Yes
Date Posted:
Date Completed:	31/03/2019
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.