Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence

NCT02226185 | Completed Phase 2 DMC

• 1 other identifier: RJ2014BH
• Study Type: interventional
• Target: 1,108
• Locations: 1 country
• Sites: 7

Brief Summary

Berberine hydrochloride is a conventional component in Chinese medicine. In recent years, anticancer activity of berberine hydrochloride have been explored. The aim of this study is to investigate the effect of berberine hydrochloride on the recurrence of colorectal adenomas.

Conditions

Colorectal Adenoma

Outcome Measures

Primary Outcomes (1)

• Recurrence rates of CRA

  The primary objective of this study is to investigate recurrence rates of colorectal adenoma (CRA) after Berberine hydrochloride or placebo intervention.

  until the last patient reached the 2 years follow-up

Secondary Outcomes (1)

• The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer

  until the last patient reached the 2 years follow-up

Other Outcomes (1)

• Changes in fecal microflora

  baseline, the 1st year and the 2nd year

Study Arms (2)

Berberine hydrochloride

EXPERIMENTAL

supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years

Drug: Berberine hydrochloride

placebo

PLACEBO COMPARATOR

identical-appearing placebo supplements for 2-3 years

Drug: placebo

Interventions

Berberine hydrochloride DRUG

supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years

Berberine hydrochloride

placebo DRUG

supplement of placebo two times per day for 2-3 years

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18-75 years
• Individuals who had at least one and no more than 6 histologically confirmed CRAs removed within 6 months before recruitment
• Individuals who are able to swallow pills

You may not qualify if:

• Individuals whose adenoma was not completely removed during previous colonoscopy
• Individuals with a history of familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (HNPCC, Lynch syndrome)
• Individuals who are taking regularly aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclo-oxygenase 2 (COX2) inhibitors, calcium or vitamin D
• Individuals with a history of subtotal/total gastrectomy or partial bowel resection
• Individuals who are intolerant to another colonoscopy examination
• Individuals who are hypersensitive or intolerant to the drugs
• Individuals with severe heart, liver or kidney disease, or any cancer history
• Individuals presenting severe constipation
• Pregnant women, women during breast-feeding period, or women with expect pregnancy
• Individuals with mental diseases who are not able to cooperate
• Individuals who are involved in designing, planning or performing this trial

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (7)

Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China

Location

Department of Gastroenterology, Zhongshan Hospital, Xiamen University

Xiamen, Fujian, China

Location

Department of Gastroenterology, Nanfang Hospital, Southern Medical Univerisity

Guangdong, Guangzhou, China

Location

Division of Gastroenterology and Hepatology, The Affiliated DrumTower of Nanjing University Medical School

Nanjing, Jiangsu, China

Location

Division of Gastroenterology and Hepatology, Ren-Ji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai Institute of Digestive Disease; Key Laboratory of Gastroenterology & Hepatology, Ministry of Health

Shanghai, Shanghai Municipality, 200001, China

Location

Department of Gastroenterology, the Shanghai Tenth People's Hospital, Tongji University

Shanghai, Shanghai Municipality, China

Location

Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University

Tianjin, Tianjin Municipality, China

Location

Related Publications (2)

• Qian Y, Kang Z, Zhao L, Chen H, Zhou C, Gao Q, Wang Z, Liu Q, Cui Y, Li X, Chen Y, Zou T, Fang J. Berberine might block colorectal carcinogenesis by inhibiting the regulation of B-cell function by Veillonella parvula. Chin Med J (Engl). 2023 Nov 20;136(22):2722-2731. doi: 10.1097/CM9.0000000000002752. Epub 2023 Aug 9.

  PMID: 37553874 DERIVED

• Chen YX, Gao QY, Zou TH, Wang BM, Liu SD, Sheng JQ, Ren JL, Zou XP, Liu ZJ, Song YY, Xiao B, Sun XM, Dou XT, Cao HL, Yang XN, Li N, Kang Q, Zhu W, Xu HZ, Chen HM, Cao XC, Fang JY. Berberine versus placebo for the prevention of recurrence of colorectal adenoma: a multicentre, double-blinded, randomised controlled study. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):267-275. doi: 10.1016/S2468-1253(19)30409-1. Epub 2020 Jan 8.

  PMID: 31926918 DERIVED

Study Officials

• Jing-Yuan Fang, M.D., Ph.D

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Gastroenterology

Study Record Dates

• First Submitted: August 23, 2014
• First Posted: August 27, 2014
• Study Start: November 1, 2014
• Primary Completion: December 29, 2018
• Study Completion: December 29, 2018
• Last Updated: March 26, 2019

Record last verified: 2019-03

Locations

CN (7)