Drinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation

Study Overview
=================
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).

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

Conditions
-----------------
Chronic Constipation

Intervention / Treatment
-----------------
* Device: Electrolyzed Alkaline Ionizer


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: comparison between baseline and post-treatment in single group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EHARW Treatment group<br>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<br>* 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.<br>* 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 |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
constipation, hydrogen-rich alkaline ionized water, complete spontaneous bowel movement, patient assessment of constipation-symptoms, patient assessment of constipation-quality of life