Drinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation

Chronic Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05734859
• Other study ID #: EMB-2022-03
• Status: Completed
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: January 13, 2023

Study information

• Verified date: March 2023
• Source: Wonju Severance Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 13, 2023
• Est. primary completion date: January 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• Men and women aged 19 to 70 years old
• Those who meet the criteria for Roma ? 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

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Wonju College of Medicine	Wonju	Ganwon-do

Sponsors (1)

Lead Sponsor	Collaborator
Wonju Severance Christian Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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