Effects of Psyllium on Constipation in Schizo-phrenic: A Randomized Controlled Crossover Trial

Nurse Practitioner

Constipation in schizophrenia is an important issue in clinical care. Constipation needs psychiatric professionals concerning and providing intervention because it may cause ileus and lead to death. The cause of constipation in patients may be due to side effects of antipsychotic medication, sedentary lifestyle, insufficient water intake, fiber, etc. The study aims to increase fiber of the consumption of psyllium to assess the constipation effectiveness in schizophrenics. The study conducted a crossover research design. G-power was used to calculate the 22 subjects in each of the two groups. A total of 44 patients with constipation who were schizophrenics will participate in the study. Patients will use simple randomly to be divided into two groups based on their live ward for pre-testing. These two groups will receive either psyllium 3.5 g/day or 7 g/day for 4 weeks in a single-blind, crossover trial. The trial will stop 1week after the first phase and post-test. Then, two groups will exchange the dose for 4 weeks. Post-test will record after finishing this second phase trial. This study can understand the benefits of psyllium on schizophrenics with constipation symptoms and can give professional suggestions to patients with constipation in the future.

Study Overview

• Status: Not yet recruiting
• Conditions: Schizophrenia; Constipation; Psyllium
• Intervention / Treatment: Dietary supplement: Psyllium huks

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Puxin Township
    • Chang Hua, Puxin Township, Taiwan, 513011
      • Changhua Hospitol
      • Contact: Chin-Hsiu Wang; Phone Number: 5006 886-048298686; Email: 232936showshow@gmail.com
      • Contact: Mei-Ling Lin; Phone Number: 7083 886-0426315682; Email: linml@sunrise.hk.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. DSM-V was diagnoses with schizophrenia inpatients.
2. Aged between 20 years and above.
3. Those who defecate less than 3 times a week, or those who have Bristol stool form scale between 1 and 2, or those who have constipation assessment scale (CAS) scores more than one point from questions 3 to 8; Or use PRN stool softeners (including oral and suppository) at least once a week.
4. Clear awareness and able to communicate in Chinese and Taiwanese.

Exclusion Criteria:

1. Patients with intestinal diseases such as colon cancer, irritable bowel syndrome and other organic intestinal diseases such as rectal bleeding, intestinal surgery, rectal prolapse and other medical history.
2. Cases with positive fecal occult blood test in the past six months, changes in stool thickness for one month, history of iron deficiency anemia, and unexplained weight loss for one month.
3. Those who are unable to cooperate due to obvious mental symptoms.
4. History of grain allergy, asthma.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; In a single-blind crossover trial (male or female), these groups will receive 3.5 g/day or 7 g/day of psyllium for 4 weeks. The trial will stop 1 week after the first phase and post-test. The two groups will then swap doses for 4 weeks. Post-tests will be recorded upon completion of this Phase 2 trial. After completing the trial, determine the dose effect.	Dietary supplement: Psyllium huks; psyllium in 250ml of water
Experimental: B; In a single-blind crossover trial (male or female), these groups will receive 3.5 g/day or 7 g/day of psyllium for 4 weeks. The trial will stop 1 week after the first phase and post-test. The two groups will then swap doses for 4 weeks. Post-tests will be recorded upon completion of this Phase 2 trial. After completing the trial, determine the dose effect.	Dietary supplement: Psyllium huks; psyllium in 250ml of water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bowel movement	increased stool frequency	4weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool type	improved stool type (bristol stool form)	4weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constipation Assessment Scale, CAS	improved constipation symptoms	4weeks

Collaborators and Investigators

• Sponsor: Hungkuang University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Constipation; Gastrointestinal Agents; Cathartics; Psyllium
• Other Study ID Numbers: Hungkuang University

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