Effectiveness of an amino acid beverage formulation in diarrhea-predominant irritable bowel syndrome: A pragmatic real-world study

Table 1 Baseline socio-demographic details

Characteristic	n = 1001
Sex
Female	67 (67%)
Male	33 (33%)
Age (mean, SD)	39.7 (10.6)
Ethnicity
American Indian/Alaska Native	8 (8%)
Asian	2 (2%)
Black	9 (9%)
Native Hawaiian or other Pacific islander	1 (1%)
White	80 (80%)
Hispanic
Hispanic/Latino	10 (10%)
Non-Hispanic	90 (90%)
IBS-D features
Met Rome IV Criteria	100 (100%)
Number of patients with > 4 d experiencing type 4/5 stools	100 (100%)
Average BSFS	6 (0.1)
Average pain-NRS	6 (0.2)
IBS-SSS2	314 (77)
FBDSI	195 (52.6)

¹n (%) or mean (SD).

²n = 71 (only 71 pairs of the irritable bowel syndrome severity scoring system were completed by participants).

IBS-SSS: Irritable bowel syndrome severity scoring system; BSFS: Bristol Stool Form Scale; NRS: Numeric rating scale; FBDSI: Functional Bowel Disorder Severity Index; IBS-D: Diarrhea predominant irritable bowel syndrome.

Table 2 Overview of standard of care practices

Dietary modifications	n = 1001	Concomitant supplements	n = 1001	Concomitant medication	n = 1001
FODMAP	50 (50%)	Prebiotics	60 (60%)	Rifaximin	35 (35%)
Gluten-free	51 (51%)	Probiotics	76 (76%)	Eluxadoline	22 (22%)
Keto	36 (36%)	Peppermint oil	45 (45%)	Antispasmodics	12 (12%)
Elimination	50 (50%)	Fiber	86 (86%)	SSRIs	8 (8%)
High fiber	53 (53%)	Ginger	52 (52%)	Tricyclic antidepressant	8 (8%)
Low fiber	43 (43%)	Magnesium	55 (55%)	Anticholinergic medication	14 (14%)
-	-	Vitamin D	57 (57%)	Antidiarrheal medications	32 (32%)
-	-	-	-	Bile acid sequestrants	9 (9%)
-	-	-	-	Ondansetron	8 (8%)

¹n (%).

FODMAP: Fermentable oligosaccharides, disaccharides, monosaccharides, and polyols; SSRIs: Selective serotonin reuptake inhibitors.

Table 3 Diarrhea predominant irritable bowel syndrome responder analysis

Characteristic	n (%)
BSFS responder (n = 100)	40 (40%)
Pain responder (n = 96)	51 (53%)
Discomfort responder (n = 96)	53 (55%)
Composite responder (pain) (n = 96)	24 (25%)
Composite responder (discomfort) (n = 96)	24 (25%)
IBS-SSS (n = 71)	36 (51%)

IBS-SSS: Irritable bowel syndrome severity scoring system; BSFS: Bristol Stool Form Scale.

Table 4 Overview of maximum weekly urgency experienced between baseline and intervention period

Urgency	n = 981
Category change
Significant improvement	8 (8%)
Moderate improvement	9 (9%)
Mild improvement	40 (41%)
No change	40 (41%)
Mild worsening	1 (1%)

¹n (%).