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

Not Applicable

Completed

• Conditions: Schizophrenia; Constipation
• Interventions: Dietary Supplement: Psyllium huks

• Registration Number: NCT05528146
• Lead Sponsor: Hungkuang University

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.

Detailed Description

The study was conducted in the psychiatric department of a hospital in the central region and utilized a crossover design involving a total of 42 patients with schizophrenia. The study employed a single-blind and simple randomization approach, with hospital wards divided into two groups. 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. The research findings showed significant improvements in the frequency of constipation, stool consistency, and subjective experience of bowel movements in patients with schizophrenia following the intervention with psyllium husk.

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-06
• Study Start: 2023-03-01
• Primary Completion: 2023-07-07
• Study Completion: 2023-07-07
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Psyllium huks	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.
B	Psyllium huks	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.

Primary Outcome Measures

Name	Time	Method
frequency of constipation	4weeks	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

Secondary Outcome Measures

Name	Time	Method
Stool type(bristol stool form)	4weeks	To assess the outcome measure of stool consistency, researchers will utilize the Bristol Stool Scale, which categorizes stool types into seven categories. These categories will be further classified into three groups: constipation, normal, and diarrhea. Constipation, in this context, is defined as the presence of stool types falling within the constipation category, as specified on the Bristol Stool Scale. Researchers will collect this data through daily inquiries with participants and record any associated discomfort or symptoms related to constipation.; The Wilcoxon Signed Rank Test counted the stool patterns of the subjects and found that when taking 3.5g/day psyllium husk, the constipation pattern was reduced (z = -3.08, p = .002, Cohen's d= .54) , the amount of effect was reached; and the normal stool pattern increased (z = -4.35, p = \< .001, Cohen's d = - .89).

Trial Locations

Locations (1)

Changhua Hospitol; 🇨🇳 Chang Hua, Puxin Township, Taiwan