Drinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation

A Pilot Study of Drinking Electrolyzed Hydrogen-rich Alkaline Reduced Water Generated by Alkaline Ionizer (BTM-1200) on the Chronic Functional Constipation

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.

Study Overview

• Status: Completed
• Conditions: Chronic Constipation
• Intervention / Treatment: Device: Electrolyzed Alkaline Ionizer

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).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ganwon-do
    • Wonju, Ganwon-do, Korea, Republic of, 26426
      • Wonju College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EHARW Treatment group; The experimental group will drink a total amount of 20 mL/ kg body weight/day of EHARW for 4 weeks on an empty stomach according to the researcher's instruction.	Device: Electrolyzed Alkaline Ionizer; Patients will drink EHARW calculated by 20 mL/kg body weight/day which can be divided into several times a day for drinking. The patient is recommended to drink water in an empty stomach and to drink water generated from the device as soon as possible.; Other Names: BTM-1200

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete spontaneous bowel movement (CSBM) frequency	CSBM is used to access the frequency of bowel movement. This indicates the efficacy of EHARW (pH 9.5) after 4-weeks of treatment in chronic constipation patients.	4 weeks treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient assessment of constipation-symptoms (PAC-SYM) Questionnaire	PAC-SYM is used to access constipation symptoms of patient before and after the intervention. This tool is categorized into 3 (abdominal, rectal, stool), and includes total 12 questions. Higher score present improvement of constipation symptoms.	4 weeks treatment
Patient assessment of constipation-quality of life (PAC-QOL) Questionnaire	PAC-QOL is used to access constipation-related quality of life before and after the intervention. This tool is categorized into 4: physical discomfort, psychological discomfort, worries and satisfaction, and consists of 28 questions. Higher score present improvement of constipation symptoms.	4 weeks treatment
Bristol stool scale score	Fecal form is accessed by using Bristol stool scale. Fecal form indicate hardness of stool. Higher score present improvement of constipation symptoms. Similarly other questionnaires using self observation diary was also assessed including straining at defecation, stiffness of the stool, sensation of incomplete evacuation, and sensation of obstruction.	4 weeks treatment

Collaborators and Investigators

• Sponsor: Wonju Severance Christian Hospital
• Investigators: Principal Investigator: Kyu-Jae Lee, Ph.D., Department of Convergence Medicine, Wonju College of Medicine, Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Actual): January 13, 2023
• Study Completion (Actual): January 13, 2023

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: constipation; hydrogen-rich alkaline ionized water; complete spontaneous bowel movement; patient assessment of constipation-symptoms; patient assessment of constipation-quality of life
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: EMB-2022-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No