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

NCT05528146 | Completed

• 1 other identifier: Hungkuang University
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia; Constipation

Keywords

Schizophrenia; Psyllium; Constipation

Outcome Measures

Primary Outcomes (1)

• frequency of constipation

  To assess the outcome measure of constipation frequency, researchers will collect the number of weekly bowel movements from participants by daily inquiries. Constipation, in this context, is defined as having fewer than three bowel movements per week. Additionally, researchers will record any associated discomfort or symptoms related to constipation. Wilcoxon Signed Rank Test analysis showed a significant difference between the pre-test and the second stage (3.5 g/day psyllium) (z = -2.08, p = .04), Cohen's d = .39; the pre-test and the three stage (7 g/day psyllium), there was a statistically significant difference (z = -2.2, p = .03) , Cohen's d = .42

  4weeks

Secondary Outcomes (1)

• Stool type(bristol stool form)

  4weeks

Other Outcomes (1)

• Constipation Assessment Scale, CAS

  4weeks

Study Arms (2)

A group for women

EXPERIMENTAL

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

B group for man

EXPERIMENTAL

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

Interventions

Psyllium huks DIETARY_SUPPLEMENT

psyllium in 250ml of water

A group for women; B group for man

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-V was diagnoses with schizophrenia inpatients.
• Aged between 20 years and above.
• 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.
• Clear awareness and able to communicate in Chinese and Taiwanese.

You may not qualify if:

• 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.
• 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.
• Those who are unable to cooperate due to obvious mental symptoms.
• History of grain allergy, asthma.

Sponsors & Collaborators

• Hungkuang University: lead

Study Sites (1)

Changhua Hospitol

Chang-hua, Puxin Township, 513011, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia; Constipation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study employed a single-blind and simple randomization approach, with hospital wards divided into two groups. Only Researchers Know Psyllium Dosage.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Practitioner

Model Details: During the first stage, both groups underwent pre-tests before the intervention. In the second stage, the two groups separately received a daily intake of 3.5 grams and 7 grams of psyllium husk for four weeks, followed by the first post-test. There was then a one-week washout period. In the third stage, the two groups switched the intake dosage of psyllium husk and underwent the second post-test after another four weeks of continuous intake.

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: March 1, 2023
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: May 7, 2025

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)