NCT02772692

Brief Summary

Whether functional consumption is influenced by defecation postures is unclear. The investigators investigated effects of defecation postures on functional consumption.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

8 months

First QC Date

May 11, 2016

Last Update Submit

May 12, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frequency of defecation

    Frequency of defecation per week is collected by an interview questionnaire.

    Six months

Secondary Outcomes (4)

  • Frequency of re-defecation after the first defecation

    Six months

  • Defecation time

    Six months

  • Sensation of non-complete defecation

    Six months

  • Straining forces during defecation

    Six months

Study Arms (2)

Squatting pan

EXPERIMENTAL

Defecation using a squatting pan

Behavioral: Squatting pan

Toilet

NO INTERVENTION

defecation using a standard-sized toilet

Interventions

Squatting panBEHAVIORAL

Using squatting pans to replace standard-sized toilets in one group of the included constipation patients

Squatting pan

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has functional constipation
  • Subject does not receive other treatments

You may not qualify if:

  • History of heart cerebrovascular disease
  • History of other types of constipation
  • Pregnant, trying to become pregnant or breast feeding
  • Age\< 18-year and \>70-year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Roberts MC, Millikan RC, Galanko JA, Martin C, Sandler RS. Constipation, laxative use, and colon cancer in a North Carolina population. Am J Gastroenterol. 2003 Apr;98(4):857-64. doi: 10.1111/j.1572-0241.2003.07386.x.

  • Lindberg G, Hamid SS, Malfertheiner P, Thomsen OO, Fernandez LB, Garisch J, Thomson A, Goh KL, Tandon R, Fedail S, Wong BC, Khan AG, Krabshuis JH, LeMair A; World Gastroenterology Organisation. World Gastroenterology Organisation global guideline: Constipation--a global perspective. J Clin Gastroenterol. 2011 Jul;45(6):483-7. doi: 10.1097/MCG.0b013e31820fb914. No abstract available.

  • Rao SS, Kavlock R, Rao S. Influence of body position and stool characteristics on defecation in humans. Am J Gastroenterol. 2006 Dec;101(12):2790-6. doi: 10.1111/j.1572-0241.2006.00827.x. Epub 2006 Oct 6.

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Qingchuan Zhao, MD

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhanwei Zhao, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 11, 2016

First Posted

May 13, 2016

Study Start

May 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

May 13, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share