Effects of Synbiotics on FC and Other Contributing Factors

NCT04620317 | Completed

• 1 other identifier: SynFC_001
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prevalence of functional constipation (FC) was first determined with 15.2% reported. Next, a 16-week randomised, double-blind, placebo-controlled study conducted to assess the improvement in functional constipation among the respective individuals by using synbiotic supplement. Throughout the intervention, it was reported that significant improvements for defecation frequency, Bristol Stool Form (BSF) scale, and Patients Assessment of Constipation Symptoms (PAC-SYM) scores were reported within synbiotic group (p \< 0.001). However, no significant different was reported when compared both groups as placebo group was found to have significant within-group difference too. Placebo effect was suspected in this study.

Conditions

Functional Constipation

Keywords

Prevalence; functional constipation; Rome III criteria; Bristol Stool Form Scale; defecation frequency; PAC-SYM; PAC-QOL; randomised controlled trial (RCT); synbiotic

Outcome Measures

Primary Outcomes (3)

• Defecation frequency

  Defecation frequency was measured through participants' self reported defecation frequency in a week.

  16 weeks

• Stool types - Bristol Stool Form (BSF) Scale

  BSF scale was used to characterise human stools to seven classifications using seven pictorial presentation of stool types.Type 1 stool shows the very slow transit time with longest time spent in the colon whereas Type 7 indicates the least time spent in the colon and has fast bowel transit time. Meanwhile, Type 4 is the most ideal stool type optimal colonic transit time.

  16 weeks

• Constipation symptoms - Patients Assessment of Constipation Symptoms (PAC-SYM)

  PAC-SYM consists of a total of 12 questions includes abdominal symptoms, rectal symptoms, and stool symptoms. It comprised with a 5-point Likert scale ranging from 0 (Absent) to 4 (Very severe). The values of subscales and total scores for PAC-SYM were then computed as average item response within the scales and for the global score. Lower score obtained indicates less symptom severity.

  16 weeks

Secondary Outcomes (2)

• Quality of life - Patients Assessment of Constipation Quality of Life (PAC-QOL)

  16 weeks

• Psychological factor - Depression, Anxiety, and Stress scale (DASS)

  16 weeks

Study Arms (2)

Synbiotic

ACTIVE COMPARATOR

The product contained three clinically studied active ingredients namely inulin-oligofructose (prebiotic; derived from chicory root), at least 6 billion (B) colony forming unit (CFU) of Lactobacillus plantarum LP01 (probiotic) and 4 B CFU of Bifidobacterium lactis BB12 (probiotic) per sachet.

Dietary Supplement: Synbiotic

Placebo

PLACEBO COMPARATOR

Placebo contains only maltodextrin without any active ingredients, equally same in physical form, freeze-dried white powder with characteristic odor and water soluble as the synbiotic supplement.

Dietary Supplement: Placebo

Interventions

Synbiotic DIETARY_SUPPLEMENT

10 billion (B) colony forming unit (CFU) of Lactobacillus plantarum LP01, Bifidobacterium lactis BB12, and inulin oligofructose

Synbiotic

Placebo DIETARY_SUPPLEMENT

Non-active ingredients - Maltodextrins

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Malaysian of either gender;
• to 65 years old;
• Body mass index (BMI) 16.0 to 29.9 kg/m2;
• Positively diagnosed with functional constipation with Rome III-defined constipation module by the gastroenterologist

You may not qualify if:

• Vulnerable groups of pregnant and breastfeeding women;
• Physically or mentally handicapped individuals;
• Diagnosed with organic constipation (constipation associated with any neoplastic diseases, neuropathy or mechanical obstruction);
• Diagnosed with cardiovascular diseases, diabetes mellitus, cancer, neurological disease or other serious illnesses or severe medical complications;
• Faced alarm features indicative of colorectal cancer, metabolic disease and a history of gastrointestinal surgery.
• To avoid the likelihood of co-intervention bias, the following respondents were excluded:
• On gastrointestinal medications;
• Consumed probiotics or synbiotic products more than once a week in two weeks preceding screening or during intervention period;
• Regularly used laxatives (more than once per week), used anticholinergics, anti-diarrheals, antibiotics or laxative in two weeks preceding screening or at any point during intervention.

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

MeSH Terms

Interventions

Synbiotics

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: November 6, 2020
• Study Start: January 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: January 1, 2018
• Last Updated: November 6, 2020

Record last verified: 2020-11