Ileal bile acid transporter inhibitors for chronic constipation in the elderly

Table 1 Summary of randomized controlled trials of elobixibat in chronic constipation

No.	Ref.	Study population, sample size	Dose of elobixibat	Outcome	Adverse events
1	Wong et al[34], 2011, United States	Women with functional constipation, n = 36	15 mg, 20 mg	Increased colonic transit at 48 hours with both doses (P < 0.001); increased stool looseness vs placebo (P < 0.005)	Abdominal cramping/pain
2	Chey et al[35], 2011, United States	Chronic idiopathic constipation, n = 190	5 mg, 10 mg, 15 mg	Increased SBM in week 1; sustained stool frequency over 8 weeks; reduced time to first SBM and CSBM in 10/15 mg groups; reduced straining and bloating (P < 0.05)	Abdominal pain, diarrhea
3	Simrén et al[32], 2011, Sweden	Idiopathic constipation, early RCT, n = 30	0.1-10 mg	Decreased colonic transit time at higher doses; increased SBM frequency and improved stool consistency	Nausea, pain, abdominal distention, diarrhea
4	Nakajima et al[36], 2018, Japan	Chronic constipation, n = 163	5 mg, 10 mg, 15 mg	Increased SBM frequency in 10/15 mg groups vs baseline and placebo (P = 0.0001); effective in CC and IBS-C subgroups	Abdominal pain, diarrhea
5	Kumagai et al[37], 2018, Japan	Adults with CC ≥ 6 months, n = 120	2.5-20 mg; PK studied	SBM ≤ 24 hours: 100% (10 mg), 88.9% (15 mg) vs 40% placebo; reduced time to first SBM	Non-dose-dependent AEs; abdominal pain more common than diarrhea and distention
6	Nakajima et al[38], 2018, Japan	Adults 20-80 years with CC ≥ 6 months; trial 1: n = 70; trial 2: n = 341	Trial 1: 10 mg for 2 weeks; trial 2: 5-15 mg for 1 year	Trial 1: Increased SBM/week at week 1 vs placebo (P < 0.0001); trial 2: Sustained increase in SBM and CSBM over 1 year	Mild abdominal pain, diarrhea
7	Manabe et al[39], 2023, Japan	Adults ≥ 60 years with CC, n = 17	10 mg vs placebo	Decreased threshold for first constant sensation (P = 0.0018); trend toward decreased desire-to-defecate volume (P = 0.0899)	None reported
8	Hatano et al[40], 2024, Japan	CC in Parkinson’s disease, n = 74	10 mg vs placebo	Increased SBM/week from 4.2 ± 2.6 to 5.9 ± 3.2 at week 4 (P = 0.0079); improved stool form, satisfaction, reduced stigma	Diarrhea most common
9	Agarwal et al[33], 2025, India	Adults with CC ≥ 6 months, n = 150	10 mg in week 1, titrated to 10-15 mg in week 2	Increased SBM frequency (P = 0.008); CSBM response 493% vs 26.8% placebo (difference 226%, 95%CI: 8.4-36.8, P = 0.005); SBM ≤ 24 hours: 51% vs 37% placebo	15.3% reported ≥ 1 AE; abdominal pain, distention, dry mouth

AE: Adverse event; CC: Chronic constipation; CI: Confidence interval; CSBM: Complete spontaneous bowel movement; CTT: Colonic transit time; IBS-C: Irritable bowel syndrome with constipation; PK: Pharmacokinetics; RCT: Randomized controlled trial; SBM: Spontaneous bowel movement.