Indigestion
Group B (50g): 21.05% reduction at Day 30 (p=0.008) vs. placebo
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Study Overview
Study Design
Randomized, double-blind, placebo-controlled, parallel-arm clinical trial with 48 participants (45 completers)
Duration
30-day intervention period with 5 scheduled visits: Screening, Baseline (Day 1), Day 5, Day 15, and Day 30
Groups
Group A: 25g FiberPrime® | Group B: 50g FiberPrime® | Group C: 25g Placebo
Study Objectives
Primary Goals
- Evaluate gastrointestinal tolerability using GSRS scores
- Assess stool consistency and frequency using Bristol Stool Form Scale
- Monitor gut microbiome modulation through metagenomic sequencing
- Analyze short-chain fatty acid production
Safety Assessment
- Track adverse events throughout 30 days
- Monitor vital signs and clinical parameters
- Assess participant compliance and tolerability
Participant Demographics
48
Randomized
Total participants enrolled in the study45
Completers
Participants who completed 30-day intervention15
Per Group
Equal distribution across all three arms18–60
Age Range
Healthy adults in normal health statusGastrointestinal Symptom Rating Scale (GSRS)
1
2
Constipation
Group A (25g): 22.41% reduction | Group B: 25.00% reduction (p<0.001)
3
Total GSRS
Group A: 11.07% improvement | Group B: 12.79% improvement at Day 30
Stool Consistency & Bowel Function
Bristol Stool Form Scale
Progressive improvement toward normal stool consistency observed in both treatment groups:
- Group A (25g): 28.16% improvement
- Group B (50g): 33.77% improvement
- Placebo: Minimal change (1.66%)
By Day 30, 60% of Group B participants achieved optimal Type 4 stool consistency.
Bowel Frequency & Evacuation
Both treatment groups showed reduced bowel frequency and evacuation time:
- Group A: 22.68% reduction
- Group B: 15.37% reduction
- Evacuation Time: ↓ 26.82% (25g) & 31.54% (50g)
Gut Microbiome Analysis
Alpha Diversity
Shannon and Simpson indices showed stable microbial diversity throughout 30-day intervention. No significant changes in species richness or evenness observed in any group.
Beta Diversity
PERMANOVA analysis revealed no significant between-timepoint differences in community composition (Group A: p=0.07; Group B: p=0.90; Group C: p=0.72).
Taxonomic Composition
Prevotella copri remained dominant species. Subtle redistribution among subdominant taxa observed in Groups A and B, with stability in Group C profiles.
Functional Pathways
KEGG analysis showed nominal increases in carbohydrate metabolism pathways (uncorrected p<0.05), consistent with saccharolytic bacterial enrichment.
Short-Chain Fatty Acid Production
13.22%
Total SCFAs
Group A (25g) increase at Day 30
15.01%
Total SCFAs
Group B (50g) increase at Day 30
19.86%
Butyrate
Group A increase from baseline
20.91%
Butyrate
Group B increase from baseline
Safety & Tolerability
Adverse Events
Total of 8 mild adverse events reported:
- Group A (25g): 2 events (13.33%)
- Group B (50g): 4 events (26.67%)
- Group C (Placebo): 2 events (13.33%)
Events included mild bloating, loss of appetite, and constipation. All resolved without intervention.
Vital Signs
All vital parameters remained within clinically normal ranges throughout study:
- Blood pressure: Normal systolic/diastolic
- Pulse rate: Stable throughout
- Body temperature: Within normal limits
- Respiratory rate: Consistent
Compliance
Group A: 100% | Group B: 99.47% | Group C: 98.93%
Tolerability
All participants demonstrated good tolerability (scores: 2.87–3.00/3.00)
Key Conclusions
01
Well Tolerated
FiberPrime® demonstrated excellent safety profile with minimal mild adverse events across both 25g and 50g doses
02
Improved Gut Health
Statistically significant reductions in gastrointestinal symptoms, particularly constipation and indigestion domains
03
Enhanced Bowel Function
Progressive improvement in stool consistency toward optimal Type 4, reduced evacuation time, and normalized bowel frequency
04
Increased SCFA Production
Significant increases in total SCFAs, acetate, propionate, and butyrate (20% increase), supporting gut microbial metabolic activity
05
Maintained Microbiome Diversity
Stable alpha and beta diversity indices indicate no disruption of gut microbial ecology at either dose level
