Clinical trial NCT05734859: Drinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation
Official title: A Pilot Study of Drinking Electrolyzed Hydrogen-rich Alkaline Reduced Water Generated by Alkaline Ionizer (BTM-1200) on the Chronic Functional Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Constipation
Keywords: constipation
hydrogen-rich alkaline ionized water
complete spontaneous bowel movement
patient assessment of constipation-symptoms
patient assessment of constipation-quality of life
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: comparison between baseline and post-treatment in single group
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to investigate drinking effect of electrolyzed hydrogen-rich alkaline reduced water (EHARW) in chronic constipation patients. The main question is that drinking EHARW will improve the symptoms of chronic constipation for 4 weeks.

Participants will drink EHARW (20 mL/kg of body weight/day) generated from the experimental device for 4 weeks.

Detailed description: Patients diagnosed with constipation will be recruited and screened according to the inclusion and exclusion criteria after sign in the informed consent form. The selected patients will be enrolled. The experimental device (BTM-1200, Bion-Tech, Gyeonggi-do, Korea) will be installed at each patient's house. The researcher will instruct patients drinking method. The patients will drink a total of 20 mL/kg of body weight/day of EHARW (pH 9.5) in 3-different times, and drink directly from the device on an empty stomach for 4 weeks. The clinical trial is conducted in a single group without a control group, and the efficacy is evaluated by comparing the symptoms of constipation pre- and post-intervention. The primary outcome is the proportion of responders based on frequency of complete complete spontaneous bowel movement (CSBM).

Eligibility criteria: Inclusion Criteria:

* Men and women aged 19 to 70 years old
* Those who meet the criteria for Roma Ⅳ function constipation
* Symptoms begin before 6 months and last for more than 3 months
* Those who do not have organic lesions that may cause constipation
* A patient who has personally signed the consent form
* If all the criteria meet

Exclusion Criteria:

* Those taking drugs such as opioid analgesics, antipsychotics, calcium blockers, and parasympathetic antagonists
* Kidney disease (renal failure, potassium excretion disorder, etc.)
* Patients with colon-related diseases (colon cancer, intestinal stenosis, rectal flow, anal fissure, rectal bleeding), diabetes, thyroid dysfunction, or anemia
* Pregnant or lactating women
* In addition to the above, those who are judged to be difficult to conduct research by the clinical trial director
* Excluded if at least one of the above criteria meet

Primary outcomes:
measure: Complete spontaneous bowel movement (CSBM) frequency
timeFrame: 4 weeks treatment
Secondary outcomes:
measure: Bristol stool scale score
timeFrame: 4 weeks treatment
measure: Patient assessment of constipation-symptoms (PAC-SYM) Questionnaire
timeFrame: 4 weeks treatment
measure: Patient assessment of constipation-quality of life (PAC-QOL) Questionnaire
timeFrame: 4 weeks treatment
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju College of Medicine
state: Ganwon-do
Study officials:
affiliation: Department of Convergence Medicine, Wonju College of Medicine, Yonsei University
name: Kyu-Jae Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: