Introduction
Gastrointestinal (GI) transit abnormalities due to dysmotility often affect multiple regions of the GI tract rather than occur in isolation. Identifying regional GI transit delays may influence clinical management. Use of wireless motility capsules (WMC) enable regional and whole GI transit times to be objectively measured; the relationship between symptom profiles and regional transit times are explored here with a new capsule device, the Atmo Capsule.
Aims & Methods
The Atmo Capsule was administered to subjects with suspected upper and/or lower gastrointestinal dysmotility. This analysis utilized data from subjects where valid transit measurements via the Atmo Capsule were available for all regions of the GI tract, and no protocol deviations pertaining to the use of contraindicated medication or inclusion criteria violations were incurred. Regional transit times were considered delayed as follows: gastric emptying ≥ 5 h; small bowel transit, ≥ 6 h; colonic transit, ≥ 59 h. Delays affecting a single region (i.e., gastric, small bowel, or colon) were considered ‘isolated’, delays affecting multiple (> 1) regions were considered ‘generalized’. Symptom profiles were assessed using the Patient Assessment of Gastrointestinal Disorders - Symptoms (PAGI-SYM) and Patient Assessment of Constipation – Symptoms (PAC-SYM) questionnaires: all patients completed the PAGI-SYM while those with symptoms suggestive of lower GI dysmotility completed the PAC-SYM. Data were analyzed via Kruskal-Wallis test.
Results
The WMC was administered to 209 subjects (median age 41; 188 female), of whom 170 had data suitable for this analysis. Delayed GI transit was identified in 100 (59%) subjects: 65 were isolated and 35 were generalized. There were no differences in overall symptom scores in subjects with no delays (PAGI-SYM, median 1.5 [IQR: 1.1, 2.1]; PAC-SYM, 2.0 [1.5, 2.6]), isolated delays (1.5 [1.0, 2.1]; 1.9 [1.2, 2.6]) and generalized transit delays (1.8 [1.4, 2.3]; 2.1 [1.4, 2.8]) (p>0.05 for both) or symptom sub-scores (Table 1). Gastric transit was delayed in 46 subjects: 19 (41%) were isolated and 27 (59%) were generalized. Colonic transit was delayed in 60 subjects: 31 (52%) were isolated and 29 (48%) were generalized. GI symptom profiles were not different in subjects with isolated and generalized transit delays for either the stomach or colon (p>0.05 for all relevant subscales).
Table 1. Symptom profiles amongst patients with no transit delay, isolated transit delay (affecting a single region) and generalized transit delay (affecting multiple regions). Data presented as median (interquartile range) and analyzed via Kruskal-Wallis test.
Questionnaire
| Subscale | None
| Isolated
| Generalized
| P value
|
Patient Assessment of Gastrointestinal Disorders – Symptoms
| Heartburn/regurgitation
| 1.6 (1.1, 1.9)
| 1.6 (0.9, 2.0)
| 1.9 (1.4, 2.3)
| 0.11 |
Nausea/vomiting
| 0.7 (0.0, 1.3)
| 0.7 (0.0, 1.3)
| 1.0 (0.3, 1.7)
| 0.39 |
Postprandial fullness
| 2.0 (1.0, 2.5)
| 2.0 (1.5, 3.0)
| 2.5 (1.5, 3.0)
| 0.47 |
Upper abdominal pain
| 1.5 (1.0, 2.1)
| 1.5 (1.0, 2.0)
| 2.0 (1.3, 2.5)
| 0.18 |
Bloating
| 2.0 (1.5, 2.6)
| 2.0 (1.0, 2.5)
| 2.0 (1.5, 2.5)
| 0.86 |
Lower abdominal pain
| 1.5 (1.0, 2.5)
| 1.5 (1.0, 2.5)
| 2.0 (1.5, 2.5)
| 0.50 |
Patient Assessment of Constipation – Symptoms
| Abdominal
| 2.3 (1.5, 2.8)
| 2.0 (1.3, 2.8)
| 2.3 (1.8, 2.9)
| 0.59 |
| Rectal | 1.5 (1.0, 2.3)
| 1.5 (0.8, 2.3)
| 1.5 (0.8, 2.4)
| 0.67 |
| Stool | 2.3 (1.8, 3.0)
| 2.0 (1.0, 2.8)
| 2.8 (1.3, 3.4)
| 0.15 |
Conclusion
WMC measurements of regional and whole GI transit using the Atmo Capsule revealed that delayed transit impacting multiple regions were common. However, symptom profiles were unable to distinguish between isolated vs. generalized transit delays, suggesting that symptoms are an unreliable predictor of abnormalities in GI transit as previously found via other transit modalities.
Disclosure
These authors disclose the following: Braden Kuo, Anthony J. Lembo, Eammon M.M. Quigley, Satish S.C. Rao, and William D. Chey serve on the Medical Advisory Board of Atmo Biosciences. Michael Cline and Baharak Moshiree served on the Medical Advisory Board of Atmo Biosciences. Braden Kuo has received funding from NIH, Vanda, Atmo Biosciences, and Takeda and has consulted for Evoke, Takeda, Ironwood, Novo Nordisk, Cindome, and Neurogastrx. Thomas Abell has received funding from Gastric Dysrhythmias, Neurogastrx, NIH GpCRC, and Vanda and has consulted for Enterra Medical, Novo Nordisk, Nuvaira, and Vanda. Anthony J. Lembo has received funding from Ardelyx, Biomerica, GSK, Ironwood, Takeda, and Vibrant and holds stock with Allurion, Bristol Myer Squibb, and J&J. Abigail Stocker has received funding from Cindome, Enterra Medical, and Vanda. William D. Chey has received funding from Atmo Biosciences, Commonwealth Diagnostics Intl, QOL Medical, and Salix; has consulted for AbbVie, Ardelyx, Biomerica, Comvita, Gemelli, Ironwood, Nestle, QOL Medical, Phathom, Redhill, Salix, Vibrant, and Takeda; has filed patents with My Nutrition Health, Digital Manometry, and Rectal Expulsion Device; and holds stock options with Coprata, Evinature, Food Marble, Kiwi Bioscience, and Modify Health. The remaining authors disclose no conflicts.