Constipation, the infrequent and hard passage of stools, is often accompanied by symptoms of bloating, discomfort, and pain, and has a negative impact on quality of life. Functional constipation results from the complex interplay between the gastrointestinal tract, the gut microbiome, the nervous system and psychological factors (i.e. anxiety, stress, trauma, and childhood conditioning), along with diet and lifestyle factors (i.e. water intake, exercise, and obesity). Increasing dietary fibre intake is a key recommendation for the management of functional constipation since this promotes bulking of the stool and improves stool transit time.¹

The benefits of fibre and polyphenols

Specific plant-based fibres offer additional benefits, supporting metabolic health, exerting antioxidant and anti-inflammatory effects, and modulating the gut microbiota.² Psyllium,^3-5 inulin,^6,7 partially hydrolysed guar gum (PHGG),^8-11 and acacia gum¹² are some specific dietary fibres that have been clinically proven to improve functional bowel health. For more than 60 years, pectin has been used in the treatment of functional constipation,¹³ with more recent evidence supporting its use in high doses to accelerate colon transit time, alleviate clinical symptoms of constipation and increase the population of healthy gut bacteria species.¹⁴ A formulation containing slippery elm has been shown to increase bowel movement frequency, and reduce straining, bloating and abdominal pain in those with irritable bowel syndrome-constipation (IBS-C).¹⁵

Fruits and vegetables are particularly rich in polyphenols that have a wide range of beneficial antioxidant, anti-inflammatory, antimicrobial, and anticancer activities.^16,17 Reviews of preclinical and clinical data of the effect of polyphenols on the gut microbiota attest to their prebiotic status.^18,19 Theobroma cacao (Cacao) is particularly interesting in the context of bowel health as it is both a rich source of fibre and flavonoids that modify the inflammatory process and exert a local effect on inflammation within the gastrointestinal tract.^20,21 Nutritional analysis of Hylocereus polyrhizus (Red Dragon Fruit) confirms its high nutritional value as it contains dietary fibre, phenolics, and essential vitamins and minerals.²² A clinical trial reports the laxative effect of whole Dragon Fruit.²³

Thus, extracts of Cacao and Red Dragon Fruit have been combined with PHGG, acacia gum, pectin, and slippery elm as sources of dietary fibre to create a prebiotic powder formulation (MediHerb Prebiotica Regenex) specifically designed to treat functional constipation by increasing bowel motions and addressing associated gastrointestinal symptoms.

Efficacy of a prebiotic formulation for treatment of functional constipation and associated gastrointestinal symptoms in adults: A randomised controlled trial

Integria Healthcare funded a three-week randomised, controlled clinical trial to assess the effect of MediHerb Prebiotica Regenex versus a minimal-effect capsule on bowel health in heathy adults with low fibre intake (mean 16 g/day) who met the Rome IV criteria for functional constipation. MediHerb Prebiotica Regenex was taken as per product instructions, i.e. 6 g in water twice daily. Sixty-one participants were enrolled into the trial. There were more female participants (n=49) than male (n=12) in the study,¹ which is reflective of females being around 85% more likely to have constipation.²⁴ The primary outcome was change in frequency of complete spontaneous bowel movements (CSBM). Secondary outcomes assessed were gastrointestinal symptoms, quality of life and mood using questionnaires. Safety and tolerability were also assessed.

Fifty-eight participants completed the study. Results indicated significant improvements in bowel movements (p<0.001) and stool consistency (p=0.001) in participants taking MediHerb Prebiotica Regenex compared to those taking the capsule. For participants allocated to the MediHerb Prebiotica Regenex group, the number of CSBM gradually increased each week through the trial (see Figure 1), with the average increasing from 2.8 at baseline to 4.9 CSBM/week at the end of the trial. The difference in mean CSBM was statistically significant after the first 7 days. In comparison, the mean in the capsule group remained almost unchanged, i.e., 2.9 at baseline to 3.0 CSBM/week at the end of the trial.

Among those taking the prebiotic powder, 93% (n=26) were classed as responders to treatment, meaning that they reported an increase by at least 1 CSBM/week. There was a wide variation in response to the treatment, with the median response being an increase of 1 CSBM/week (32%) though some participants reported an increase of up to 4 or 5 CSBM/week (see Figure 2). Only two participants (7%) were considered non-responders, defined as having no increase in CSBM/week. For those taking the capsule, most participants (55%) reported no change at end of treatment, with the remainder split between an increase by 1 CSBM/week (24%) and decrease by 1 CSBM/week (21%).

Accompanying this was a significant reduction in overall gastrointestinal symptoms (p<0.001) including abdominal (p<0.001), rectal (p=0.004) and stool (p=0.022) symptoms, such as abdominal symptoms included discomfort, bloating, stomach cramping, painful bowel movements, and straining to pass bowel movements. Scores were indicative of substantial clinical improvement.

Quality of life also significantly improved in the MediHerb Prebiotica Regenex group (p<0.001). There were significant reductions in mean scores for depression, anxiety and stress for participants in the MediHerb Prebiotica Regenex group (all p<0.001), but improvements also occurred in the capsule group. This suggests that improvement in mood during the study that was unrelated to bowel function. Safety assessment showed no difference at baseline or day 21 in either group.

Summary

This clinical study supports the understanding that increasing dietary fibre intake is a key recommendation for the management of functional constipation. When taken for 21 days as directed, MediHerb Prebiotica Regenex could reduce clinical symptoms of functional constipation in individuals with a low dietary fibre intake by increasing the frequency of bowel improvements, softening the stool, reducing associated gastrointestinal symptoms, and improving quality of life.¹

Figure 1. Number of Complete Spontaneous Bowel Motions (CSBM) Per Week¹

Figure 2. Change in Number of CSBM Per Week¹

References

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