UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomised controlled trial evaluating the efficacy of prebiotics, probiotics and synbiotics in chronic constipation; A pilot study
Title of the study (Brief title)	Randomised controlled trial evaluating the efficacy of prebiotics, probiotics and synbiotics in chronic constipation; A pilot study
Region	Japan

Condition
Condition	Chronic constipation
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the difference of the efficacy between prebiotics, probiotics, and synbiotics in patients with chronic constipation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	complete spontaneous bowel movement compared baseline and 4weeks of treatments
Key secondary outcomes	spontaneous bowel movement, Bristol Stool Form Scale, Constipation Scoring System (CSS), The Patient Assesment of Constipation Quality of Life (PAC-QOL), Gastrointestinal Symptoms Rating Scale (GSRS), evacuation symptoms (straining, sensation of incomplete evacuation, pain, and satisfaction), and amount of dietary fiber intake per day after 4weeks of treatments

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Control arm: nutritional guidance only
Interventions/Control_2	Prebiotics arm: water soluble dietary fiber intake 10g/day for 4 weeks following nutritional guidance
Interventions/Control_3	Probiotics arm: Bifidobacterium longum BB536 (1*10(11) CFU/day) for 4 weeks following nutritional guidance
Interventions/Control_4	Synbiotics arm: both water soluble dietary fiber (10g/day) and Bifidobacterium BB536 (1*10(11)CFU/day) for 4 weeks following nutritional guidance
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Chronic Constipation 1)Must include 2 or more of the followings 1. Fewer than 3 spontaneous bowel movements per week 2. Straining during more than one-fourth of defecations 3. Lumpy of hard stool (BSFS1-2) more than one-fourth of defecations 4. Sensation of incomplete evacuation more than one-fourth of defecations 5. Sensation of anorectal obstruction/blockage more than one-fourth of defecations 6. Manual maneuvers to facilitate more than one-fourth of defecations 2) Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis 3) Loose stools are rarely present without the use of laxatives Chronic constipation is diagnosed if patients meet criteria 1), 2), and 3).
Key exclusion criteria	1) rectal intussuspocion, rectal prolapse, and megacolon inducing constipation 2) secondary constipation due to psychiatric disorders, neurologic disorders, endcrine disorders, or medication (opioids, antidepressants, anticholinergic, calcium channel blockers, proton pump inhibitors) 3)mechanical obstruction 4)past history of inflammatory bowel diseases, colorectal cancer, or bowel obstruction 5)pregnant of lactating woman 6)renal failure (serum Cr>=2.0mg/dl), severe liver disorder (T-Bil >=3.0mg/dl or AST, ALT>=100U/L) 7)severe cardiovascular disorders 8)physician determined ineligible
Target sample size	40

Research contact person
Name of lead principal investigator	Takafumi Maeda
Organization	Tsujinaka Hospital Kashiwanoha
Division name	Department of Surgery
Address	148-6 Kashiwanoha Campus, 178-2 Wakashiba Kashiwa-city, Chiba
TEL	0471-37-3737
Email	takafumim@hotmail.com

Public contact
Name of contact person	Takafumi Maeda
Organization	Tsujinaka Hospital Kashiwanoha
Division name	Department of Surgery
Address	148-6 Kashiwanoha Campus, 178-2 Wakashiba Kashiwa-city, Chiba
TEL	0471-37-3737
Homepage URL
Email	takafumim@hotmail.com

Sponsor
Institute	Tsujinaka Hospital Kashiwanoha
Institute
Department

Funding Source
Organization	Taiyo Kagaku Co, LTD Clinico Co, LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Clinical Study Support Center, Wakayama Medical University
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 05 Month 15 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date	2019 Year 05 Month 31 Day
Date of closure to data entry	2019 Year 07 Month 31 Day
Date trial data considered complete	2019 Year 07 Month 31 Day
Date analysis concluded	2019 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 21 Day
Last modified on	2019 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031427